PMA P040037S154
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S154
- Product code
- NIP
- Decision date
- 2022-09-01
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Update to the acceptance criteria for radiopaque (RO) marker placement.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S154
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-09-01
- Decision code
- OK30
- Date received
- 2022-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the acceptance criteria for radiopaque (RO) marker placement.