PMA P040037S152
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- Product code
- NIP
- Decision date
- 2022-05-26
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for the labeling update to include the final results of the RELINE MAX New Enrollment Study (ISR 04-04)
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S152
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2022-05-26
- Decision code
- APPR
- Date received
- 2022-02-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the labeling update to include the final results of the RELINE MAX New Enrollment Study (ISR 04-04)