PMA P210032S003
- Device
- GORE® TAG® Thoracic Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS003 Date Received07/26/2022 Decision Date08/05/2022 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
- S003
- Product code
- MIH
- Decision date
- 2022-08-05
- 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
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2022-08-05
- Decision code
- OK30
- Date received
- 2022-07-26
- 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 and to modify the ovens used to manufacture sidebranch catheter assembly.