Device Pre-Market Approvals

  • 0 ::
      • Applicant : Medtronic Sofamor Danek USA, Inc.
        • Supplement_number : S034
          • Supplement_type : 135 Review Track For 30-Day Notice
            • Decision_date : 2010-01-14
              • Product_code : NEK
                • City : Memphis
                  • Zip : 38132
                    • Pma_number : P000058
                      • Generic_name : Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 3003120897
                                    • 1 : 2647346
                                      • 2 : 3003006544
                                        • 3 : 1000477302
                                          • 4 : 1450293
                                            • 5 : 1824199
                                          • Device_name : Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
                                            • Device_class : 3
                                              • Medical_specialty_description : Unknown
                                                • Registration_number ::
                                                    • 0 : 1030489
                                                      • 1 : 1450293
                                                        • 2 : 2647346
                                                          • 3 : 3003006544
                                                            • 4 : 3003120897
                                                              • 5 : 1824199
                                                        • State : TN
                                                          • Date_received : 2009-09-01
                                                            • Trade_name : INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
                                                              • Supplement_reason : Process Change - Manufacturer/Sterilizer/Packager/Supplier
                                                                • Advisory_committee_description : Orthopedic
                                                                  • Zip_ext :
                                                                    • Street_1 : 1800 Pyramid Place
                                                                      • Street_2 :
                                                                        • Docket_number :
                                                                          • Decision_code : APPR
                                                                            • Advisory_committee : OR
                                                                              • Expedited_review_flag : N
                                                                                • Ao_statement : APPROVAL FOR THE REMOVAL OF ELLMAN¿S ASSAY AND SDS-PAGE SILVER STAIN TESTS FROM THE RHBMP-2 DRUG SUBSTANCE RELEASE SPECIFICATION.

Device Pre-Market Approvals

  • 1 ::
      • Applicant : Boston Scientific Corp.
        • Supplement_number : S194
          • Supplement_type : Real-Time Process
            • Decision_date : 2008-12-11
              • Product_code : LWP
                • City : ST. PAUL
                  • Zip : 55112
                    • Pma_number : P010012
                      • Generic_name : Implantable pulse generator, pacemaker (non-CRT)
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 3004105270
                                    • 1 : 2124215
                                      • 2 : 3002618605
                                        • 3 : 3008377825
                                          • 4 : 3007805252
                                            • 5 : 3002807576
                                              • 6 : 2017865
                                                • 7 : 3008253553
                                                  • 8 : 2938836
                                                    • 9 : 3005700659
                                                      • 10 : 3002806500
                                                        • 11 : 3003615065
                                                          • 12 : 3004369318
                                                            • 13 : 3008483389
                                                              • 14 : 3008973940
                                                                • 15 : 1450662
                                                                  • 16 : 3000203466
                                                                    • 17 : 1721676
                                                                      • 18 : 1028232
                                                                        • 19 : 2024024
                                                                          • 20 : 3009380063
                                                                            • 21 : 3006705815
                                                                              • 22 : 3004593495
                                                                                • 23 : 3003574398
                                                                                  • 24 : 3008159616
                                                                                    • 25 : 1000165971
                                                                                      • 26 : 3005334138
                                                                                        • 27 : 2648729
                                                                                          • 28 : 2182208
                                                                                            • 29 : 2649622
                                                                                          • Device_name : Implantable Pulse Generator, Pacemaker (Non-Crt)
                                                                                            • Device_class : 3
                                                                                              • Medical_specialty_description : Unknown
                                                                                                • Registration_number ::
                                                                                                    • 0 : 3004105270
                                                                                                      • 1 : 2124215
                                                                                                        • 2 : 2133641
                                                                                                          • 3 : 2135338
                                                                                                            • 4 : 3008494315
                                                                                                              • 5 : 3007805252
                                                                                                                • 6 : 9614453
                                                                                                                  • 7 : 2017865
                                                                                                                    • 8 : 3008253553
                                                                                                                      • 9 : 2938836
                                                                                                                        • 10 : 3003615065
                                                                                                                          • 11 : 9616693
                                                                                                                            • 12 : 3008483389
                                                                                                                              • 13 : 2032521
                                                                                                                                • 14 : 3008973940
                                                                                                                                  • 15 : 1450662
                                                                                                                                    • 16 : 9610139
                                                                                                                                      • 17 : 1721676
                                                                                                                                        • 18 : 1028232
                                                                                                                                          • 19 : 2024024
                                                                                                                                            • 20 : 3009380063
                                                                                                                                              • 21 : 3004209178
                                                                                                                                                • 22 : 3006705815
                                                                                                                                                  • 23 : 3004593495
                                                                                                                                                    • 24 : 3008159616
                                                                                                                                                      • 25 : 1000165971
                                                                                                                                                        • 26 : 3005334138
                                                                                                                                                          • 27 : 2648729
                                                                                                                                                            • 28 : 2182208
                                                                                                                                                              • 29 : 2649622
                                                                                                                                                        • State : MN
                                                                                                                                                          • Date_received : 2008-11-06
                                                                                                                                                            • Trade_name : COGNIS CARDIAC RESYNCHRONIZATION HE DEFIBRILLATOR
                                                                                                                                                              • Supplement_reason : Change Design/Components/Specifications/Material
                                                                                                                                                                • Advisory_committee_description : Cardiovascular
                                                                                                                                                                  • Zip_ext :
                                                                                                                                                                    • Street_1 : 4100 HAMLINE AVE NORTH
                                                                                                                                                                      • Street_2 :
                                                                                                                                                                        • Docket_number :
                                                                                                                                                                          • Decision_code : APPR
                                                                                                                                                                            • Advisory_committee : CV
                                                                                                                                                                              • Expedited_review_flag : N
                                                                                                                                                                                • Ao_statement : APPROVAL FOR THE PROGRAMMER SW MODEL 2868 V1.04 AND NOMINAL PARAMETERS LOADED DURING MANUFACTURING.

Device Pre-Market Approvals

  • 2 ::
      • Applicant : BAUSCH & LOMB
        • Supplement_number : S001
          • Supplement_type : Real-Time Process
            • Decision_date : 2004-08-02
              • Product_code : NUU
                • City : ROCHESTER
                  • Zip : 14603
                    • Pma_number : P010062
                      • Generic_name : Lens, contact, orthokeratology, overnight
                        • Openfda ::
                            • Regulation_number : 886.5916
                              • Fei_number ::
                                  • 0 : 2017777
                                    • 1 : 3014175039
                                      • 2 : 1000140384
                                        • 3 : 3003295911
                                          • 4 : 2020433
                                            • 5 : 1317628
                                              • 6 : 1281950
                                                • 7 : 3003900215
                                                  • 8 : 1000305608
                                                    • 9 : 3002652243
                                                      • 10 : 3002807465
                                                    • Device_name : Lens, Contact, Orthokeratology, Overnight
                                                      • Device_class : 3
                                                        • Medical_specialty_description : Ophthalmic
                                                          • Registration_number ::
                                                              • 0 : 1066578
                                                                • 1 : 3014175039
                                                                  • 2 : 2032336
                                                                    • 3 : 2020433
                                                                      • 4 : 1281950
                                                                        • 5 : 3003900215
                                                                          • 6 : 1313525
                                                                            • 7 : 3002652243
                                                                              • 8 : 9612500
                                                                                • 9 : 2031102
                                                                                  • 10 : 1223801
                                                                            • State : NY
                                                                              • Date_received : 2004-07-06
                                                                                • Trade_name : BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT
                                                                                  • Supplement_reason : Labeling Change - Indications/instructions/shelf life/tradename
                                                                                    • Advisory_committee_description : Ophthalmic
                                                                                      • Zip_ext : 0450
                                                                                        • Street_1 : 1400 NORTH GOODMAN ST.
                                                                                          • Street_2 :
                                                                                            • Docket_number :
                                                                                              • Decision_code : APPR
                                                                                                • Advisory_committee : OP
                                                                                                  • Expedited_review_flag : N
                                                                                                    • Ao_statement : APPROVAL FOR THE PROTOCOL TO BE USED TO ADD CONTACT LENS FINISHING LABORATORIES TO MANUFACTURE THE SUBJECT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT AND IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.5 DIOPTERS. THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.

Device Pre-Market Approvals

  • 3 ::
      • Applicant : MEDTRONIC Inc.
        • Supplement_number : S024
          • Supplement_type : Real-Time Process
            • Decision_date : 2006-08-31
              • Product_code : LWP
                • City : MOUNDS VIEW
                  • Zip : 55112
                    • Pma_number : P010015
                      • Generic_name : Implantable pulse generator, pacemaker (non-CRT)
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 3004105270
                                    • 1 : 2124215
                                      • 2 : 3002618605
                                        • 3 : 3008377825
                                          • 4 : 3007805252
                                            • 5 : 3002807576
                                              • 6 : 2017865
                                                • 7 : 3008253553
                                                  • 8 : 2938836
                                                    • 9 : 3005700659
                                                      • 10 : 3002806500
                                                        • 11 : 3003615065
                                                          • 12 : 3004369318
                                                            • 13 : 3008483389
                                                              • 14 : 3008973940
                                                                • 15 : 1450662
                                                                  • 16 : 3000203466
                                                                    • 17 : 1721676
                                                                      • 18 : 1028232
                                                                        • 19 : 2024024
                                                                          • 20 : 3009380063
                                                                            • 21 : 3006705815
                                                                              • 22 : 3004593495
                                                                                • 23 : 3003574398
                                                                                  • 24 : 3008159616
                                                                                    • 25 : 1000165971
                                                                                      • 26 : 3005334138
                                                                                        • 27 : 2648729
                                                                                          • 28 : 2182208
                                                                                            • 29 : 2649622
                                                                                          • Device_name : Implantable Pulse Generator, Pacemaker (Non-Crt)
                                                                                            • Device_class : 3
                                                                                              • Medical_specialty_description : Unknown
                                                                                                • Registration_number ::
                                                                                                    • 0 : 3004105270
                                                                                                      • 1 : 2124215
                                                                                                        • 2 : 2133641
                                                                                                          • 3 : 2135338
                                                                                                            • 4 : 3008494315
                                                                                                              • 5 : 3007805252
                                                                                                                • 6 : 9614453
                                                                                                                  • 7 : 2017865
                                                                                                                    • 8 : 3008253553
                                                                                                                      • 9 : 2938836
                                                                                                                        • 10 : 3003615065
                                                                                                                          • 11 : 9616693
                                                                                                                            • 12 : 3008483389
                                                                                                                              • 13 : 2032521
                                                                                                                                • 14 : 3008973940
                                                                                                                                  • 15 : 1450662
                                                                                                                                    • 16 : 9610139
                                                                                                                                      • 17 : 1721676
                                                                                                                                        • 18 : 1028232
                                                                                                                                          • 19 : 2024024
                                                                                                                                            • 20 : 3009380063
                                                                                                                                              • 21 : 3004209178
                                                                                                                                                • 22 : 3006705815
                                                                                                                                                  • 23 : 3004593495
                                                                                                                                                    • 24 : 3008159616
                                                                                                                                                      • 25 : 1000165971
                                                                                                                                                        • 26 : 3005334138
                                                                                                                                                          • 27 : 2648729
                                                                                                                                                            • 28 : 2182208
                                                                                                                                                              • 29 : 2649622
                                                                                                                                                        • State : MN
                                                                                                                                                          • Date_received : 2006-07-21
                                                                                                                                                            • Trade_name : INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES
                                                                                                                                                              • Supplement_reason : Change Design/Components/Specifications/Material
                                                                                                                                                                • Advisory_committee_description : Cardiovascular
                                                                                                                                                                  • Zip_ext :
                                                                                                                                                                    • Street_1 : 8200 CORAL SEA STREET NE
                                                                                                                                                                      • Street_2 : MS MV S11
                                                                                                                                                                        • Docket_number :
                                                                                                                                                                          • Decision_code : APPR
                                                                                                                                                                            • Advisory_committee : CV
                                                                                                                                                                              • Expedited_review_flag : N
                                                                                                                                                                                • Ao_statement : APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.

Device Pre-Market Approvals

  • 4 ::
      • Applicant : DAKO NORTH AMERICA, INC.
        • Supplement_number : S005
          • Supplement_type : Normal 180 Day Track No User Fee
            • Decision_date : 2017-05-03
              • Product_code : PLS
                • City : CARPINTERIA
                  • Zip : 93013
                    • Pma_number : P150025
                      • Generic_name : Immunohistochemistry assay, antibody, programmed death-ligand 1
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 2022180
                                    • 1 : 3002806778
                                      • 2 : 1000125183
                                    • Device_name : Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
                                      • Device_class : 3
                                        • Medical_specialty_description : Unknown
                                          • Registration_number ::
                                              • 0 : 2022180
                                                • 1 : 2028492
                                                  • 2 : 9610099
                                            • State : CA
                                              • Date_received : 2016-12-29
                                                • Trade_name : PD-L1 IHC 28-8 pharmDx
                                                  • Supplement_reason : Labeling Change - PAS
                                                    • Advisory_committee_description : Pathology
                                                      • Zip_ext :
                                                        • Street_1 : 6392 VIA REAL
                                                          • Street_2 :
                                                            • Docket_number :
                                                              • Decision_code : APPR
                                                                • Advisory_committee : PA
                                                                  • Expedited_review_flag : N
                                                                    • Ao_statement : Approval for the device which will be marketed under the trade name PD-L1 IHC 28 - 8 pharmDx and is indicated for a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®.