PMA P210032S002
- Device
- GORE® TAG® Thoracic Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS002 Date Received06/22/2022 Decision Date07/21/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P210032
- Supplement
- S002
- Product code
- MIH
- Decision date
- 2022-07-21
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
Current openFDA PMA Record
- Device
- GORE® TAG® Thoracic Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P210032
- Supplement
- S002
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-07-21
- Decision code
- OK30
- Date received
- 2022-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a pneumatic sample cutter and revised release and warning limits for heparin surface activity testing.