Device Pre-Market Approvals

  • 0 ::
      • 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

  • 1 ::
      • 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

  • 2 ::
      • 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.

Device Pre-Market Approvals

  • 3 ::
      • Applicant : Boston Scientific Corp.
        • Supplement_number : S101
          • Supplement_type : 30-Day Notice
            • Decision_date : 2010-04-06
              • Product_code : LGW
                • City : Valencia
                  • Zip : 91355
                    • Pma_number : P030017
                      • Generic_name : STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 2024311
                                    • 1 : 3006630150
                                      • 2 : 3010367940
                                        • 3 : 3007014520
                                          • 4 : 3002618605
                                            • 5 : 3004927096
                                              • 6 : 1000132370
                                                • 7 : 2017865
                                                  • 8 : 3005700659
                                                    • 9 : 3004369318
                                                      • 10 : 2124215
                                                        • 11 : 3007566237
                                                          • 12 : 3010877431
                                                            • 13 : 2183787
                                                              • 14 : 1627487
                                                                • 15 : 3009265194
                                                                  • 16 : 3000203466
                                                                    • 17 : 3013023969
                                                                      • 18 : 3010531069
                                                                        • 19 : 2183744
                                                                          • 20 : 1000306139
                                                                            • 21 : 3003477135
                                                                              • 22 : 3011874692
                                                                                • 23 : 3009380063
                                                                                  • 24 : 1000514656
                                                                                    • 25 : 3006705815
                                                                                      • 26 : 3004593495
                                                                                        • 27 : 3003574398
                                                                                          • 28 : 3010309840
                                                                                            • 29 : 3000203066
                                                                                              • 30 : 3010326622
                                                                                                • 31 : 3008514029
                                                                                                  • 32 : 3009920161
                                                                                                    • 33 : 2182207
                                                                                                      • 34 : 2648729
                                                                                                        • 35 : 2649622
                                                                                                      • Device_name : Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
                                                                                                        • Device_class : 3
                                                                                                          • Medical_specialty_description : Unknown
                                                                                                            • Registration_number ::
                                                                                                                • 0 : 2024311
                                                                                                                  • 1 : 3006630150
                                                                                                                    • 2 : 3010367940
                                                                                                                      • 3 : 1647149
                                                                                                                        • 4 : 3007014520
                                                                                                                          • 5 : 3004927096
                                                                                                                            • 6 : 1056553
                                                                                                                              • 7 : 2133641
                                                                                                                                • 8 : 2135338
                                                                                                                                  • 9 : 2017865
                                                                                                                                    • 10 : 1422634
                                                                                                                                      • 11 : 9616693
                                                                                                                                        • 12 : 2124215
                                                                                                                                          • 13 : 2032521
                                                                                                                                            • 14 : 3007566237
                                                                                                                                              • 15 : 3010877431
                                                                                                                                                • 16 : 2183787
                                                                                                                                                  • 17 : 1627487
                                                                                                                                                    • 18 : 3009265194
                                                                                                                                                      • 19 : 3013023969
                                                                                                                                                        • 20 : 3010531069
                                                                                                                                                          • 21 : 2183744
                                                                                                                                                            • 22 : 3003477135
                                                                                                                                                              • 23 : 3011874692
                                                                                                                                                                • 24 : 3009380063
                                                                                                                                                                  • 25 : 2133810
                                                                                                                                                                    • 26 : 3004209178
                                                                                                                                                                      • 27 : 3006705815
                                                                                                                                                                        • 28 : 3004593495
                                                                                                                                                                          • 29 : 3010309840
                                                                                                                                                                            • 30 : 3010326622
                                                                                                                                                                              • 31 : 3008514029
                                                                                                                                                                                • 32 : 3009920161
                                                                                                                                                                                  • 33 : 2182207
                                                                                                                                                                                    • 34 : 2648729
                                                                                                                                                                                      • 35 : 2649622
                                                                                                                                                                                • State : CA
                                                                                                                                                                                  • Date_received : 2010-03-09
                                                                                                                                                                                    • Trade_name : PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
                                                                                                                                                                                      • Supplement_reason : Process Change - Manufacturer/Sterilizer/Packager/Supplier
                                                                                                                                                                                        • Advisory_committee_description : Neurology
                                                                                                                                                                                          • Zip_ext :
                                                                                                                                                                                            • Street_1 : 25155 Rye Canyon Loop
                                                                                                                                                                                              • Street_2 :
                                                                                                                                                                                                • Docket_number :
                                                                                                                                                                                                  • Decision_code : OK30
                                                                                                                                                                                                    • Advisory_committee : NE
                                                                                                                                                                                                      • Expedited_review_flag : N
                                                                                                                                                                                                        • Ao_statement : CONSOLIDATION TO A SINGLE COMPONENT SUPPLIER FOR THE ARTISAN 2X8 SURGICAL LEAD DISC ELECTRODE.

Device Pre-Market Approvals

  • 4 ::
      • Applicant : W. L. GORE & ASSOCIATES, INC.
        • Supplement_number : S001
          • Supplement_type : 30-Day Notice
            • Decision_date : 2005-05-10
              • Product_code : MIH
                • City : FLAGSTAFF
                  • Zip : 86003
                    • Pma_number : P040043
                      • Generic_name : SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
                        • Openfda ::
                            • Regulation_number :
                              • Fei_number ::
                                  • 0 : 2011171
                                    • 1 : 3002808486
                                      • 2 : 3003678543
                                        • 3 : 3013164176
                                          • 4 : 1824619
                                            • 5 : 3007284313
                                              • 6 : 3003528016
                                                • 7 : 1820334
                                                  • 8 : 3002807040
                                                    • 9 : 3002806434
                                                      • 10 : 3009526575
                                                        • 11 : 3013162347
                                                          • 12 : 3003292403
                                                            • 13 : 3011063223
                                                              • 14 : 3005364322
                                                                • 15 : 3008011247
                                                                  • 16 : 3007738736
                                                                    • 17 : 3004753364
                                                                      • 18 : 3002534070
                                                                        • 19 : 3003565456
                                                                          • 20 : 3002807314
                                                                            • 21 : 3007530363
                                                                              • 22 : 2017233
                                                                                • 23 : 3004497303
                                                                                  • 24 : 1000135961
                                                                                    • 25 : 1000116158
                                                                                  • Device_name : System, Endovascular Graft, Aortic Aneurysm Treatment
                                                                                    • Device_class : 3
                                                                                      • Medical_specialty_description : Unknown
                                                                                        • Registration_number ::
                                                                                            • 0 : 2011171
                                                                                              • 1 : 3002808486
                                                                                                • 2 : 3003678543
                                                                                                  • 3 : 2247858
                                                                                                    • 4 : 1824619
                                                                                                      • 5 : 3007284313
                                                                                                        • 6 : 9617601
                                                                                                          • 7 : 9710641
                                                                                                            • 8 : 1820334
                                                                                                              • 9 : 3009526575
                                                                                                                • 10 : 2532027
                                                                                                                  • 11 : 2184009
                                                                                                                    • 12 : 3013162347
                                                                                                                      • 13 : 3013164176
                                                                                                                        • 14 : 3011063223
                                                                                                                          • 15 : 3005364322
                                                                                                                            • 16 : 3008011247
                                                                                                                              • 17 : 3007738736
                                                                                                                                • 18 : 9616099
                                                                                                                                  • 19 : 3004753364
                                                                                                                                    • 20 : 9612164
                                                                                                                                      • 21 : 9680654
                                                                                                                                        • 22 : 3002807314
                                                                                                                                          • 23 : 2017233
                                                                                                                                            • 24 : 3004497303
                                                                                                                                              • 25 : 9612434
                                                                                                                                        • State : AZ
                                                                                                                                          • Date_received : 2005-04-14
                                                                                                                                            • Trade_name : GORE TAG THORACIC ENDOPROSTHESIS
                                                                                                                                              • Supplement_reason : Process Change - Manufacturer/Sterilizer/Packager/Supplier
                                                                                                                                                • Advisory_committee_description : Cardiovascular
                                                                                                                                                  • Zip_ext : 2400
                                                                                                                                                    • Street_1 : 3450 KILTIE LANE
                                                                                                                                                      • Street_2 : P.O. BOX 2400
                                                                                                                                                        • Docket_number :
                                                                                                                                                          • Decision_code : OK30
                                                                                                                                                            • Advisory_committee : CV
                                                                                                                                                              • Expedited_review_flag : N
                                                                                                                                                                • Ao_statement : ADDITION OF A NEW CLEANROOM AND CONTROLLED ENVIRONMENT AREA.