PMA P040037S091
- Device
- Gore VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S091
- Product code
- NIP
- Decision date
- 2016-09-22
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for a Post-Approval study labeling update to include the final study results for the extended follow-up 25cm Viabahn Endoprosthesis study.
Current openFDA PMA Record#
- Device
- Gore VIABAHN ENDOPROSTHESIS
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S091
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-09-22
- Decision code
- APPR
- Date received
- 2016-04-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a Post-Approval study labeling update to include the final study results for the extended follow-up 25cm Viabahn Endoprosthesis study.