Device Pre-Market Approvals

  • 0 ::
      • 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

  • 1 ::
      • 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

  • 2 ::
      • 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┬«.

Device Pre-Market Approvals

  • 3 ::
      • Applicant : Medtronic Sofamor Danek USA, Inc.
        • Supplement_number : S052
          • Supplement_type : 30-Day Notice
            • Decision_date : 2013-02-13
              • 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 : 2013-01-14
                                                            • 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 : OK30
                                                                            • Advisory_committee : OR
                                                                              • Expedited_review_flag : N
                                                                                • Ao_statement : ADDITION OF AN ALTERNATIVE WATER SUPPLIER.

Device Pre-Market Approvals

  • 4 ::
      • Applicant : MENTOR CORP.
        • Supplement_number : S030
          • Supplement_type : 30-Day Notice
            • Decision_date : 2015-09-24
              • Product_code : FTR
                • City : IRVINE
                  • Zip : 92618
                    • Pma_number : P030053
                      • Generic_name : Prosthesis, breast, noninflatable, internal, silicone gel-filled
                        • Openfda ::
                            • Regulation_number : 878.3540
                              • Fei_number ::
                                  • 0 : 2011068
                                    • 1 : 3001628772
                                      • 2 : 3006165545
                                        • 3 : 3010531069
                                          • 4 : 2182291
                                            • 5 : 3006108784
                                              • 6 : 1000118360
                                                • 7 : 3011299751
                                              • Device_name : Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
                                                • Device_class : 3
                                                  • Medical_specialty_description : General, Plastic Surgery
                                                    • Registration_number ::
                                                        • 0 : 2011068
                                                          • 1 : 3005423519
                                                            • 2 : 3010531069
                                                              • 3 : 1651189
                                                                • 4 : 2182291
                                                                  • 5 : 9617229
                                                                    • 6 : 1645337
                                                                      • 7 : 3011299751
                                                                • State : CA
                                                                  • Date_received : 2015-08-26
                                                                    • Trade_name : MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS
                                                                      • Supplement_reason : Process Change - Manufacturer/Sterilizer/Packager/Supplier
                                                                        • Advisory_committee_description : General, Plastic Surgery
                                                                          • Zip_ext :
                                                                            • Street_1 : 33 TECHNOLOGY DRIVE
                                                                              • Street_2 :
                                                                                • Docket_number :
                                                                                  • Decision_code : OK30
                                                                                    • Advisory_committee : SU
                                                                                      • Expedited_review_flag : N
                                                                                        • Ao_statement : CHANGE THE SAMPLE SIZE FOR IN-PROCESS SILICONE GEL PENETRATION TESTING CONDUCTED AT THE MENTOR IRVING, TEXAS MANUFACTURING FACILITY.