PMA P040043S127
- Device
- Conformable GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. GORE & ASSOCIATES, INC.
- PMA number
- P040043
- Supplement
- S127
- Product code
- MIHÂ
- Decision date
- 2021-05-04
- Generic name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Approval order statement
- New Quality Control Test Equipment For Testing Of The Catheter Hubs Of The Conformable GORE TAG Thoracic Endoprosthesis (CTAG) Catheters
Current openFDA PMA Record
- Device
- Conformable GORE TAG Thoracic Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040043
- Supplement
- S127
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-05-04
- Decision code
- OK30
- Date received
- 2021-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New quality control test equipment for testing of the catheter hubs of the Conformable GORE TAG Thoracic Endoprosthesis (CTAG) catheters.