PMA P040043S130
- Device
- GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. GORE & ASSOCIATES, INC.3450 Kiltie Lanep.o. Box 2400flagstaff, AZ 86003-2400 PMA NumberP040043 Supplement NumberS130 Date Received01/20/2022 Decision Date02/22/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P040043
- Supplement
- S130
- Product code
- MIH
- Decision date
- 2022-02-22
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
Current openFDA PMA Record
- Device
- GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S130
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-02-22
- Decision code
- OK30
- Date received
- 2022-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of cytotoxicity and infrared spectroscopy inspections for incoming components.