PMA P040043S124

Device: GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S124
Product code: MIH
Decision date: 2021-03-25
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: implementation of an FEP formulation change by a sub-tier supplier in the manufacturing of Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device), GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SYSTEM (CMDS Device) and GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Bifurcated Component (IBE IBC Device).

Current openFDA PMA Record#

Device: GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S124
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-03-25
Decision code: OK30
Date received: 2021-02-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an FEP formulation change by a sub-tier supplier in the manufacturing of Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device), GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SYSTEM (CMDS Device) and GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Bifurcated Component (IBE IBC Device).