PMA P040043S128

Device: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S128
Product code: MIH
Decision date: 2021-05-04
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of an alternate manufacturing process, using a second-generation equipment, to manufacture a sleeve component for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System Device.

Current openFDA PMA Record#

Device: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S128
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-05-04
Decision code: OK30
Date received: 2021-04-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate manufacturing process, using a second-generation equipment, to manufacture a sleeve component for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System Device.