PMA P040037S123
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S123
- Product code
- NIP
- Decision date
- 2019-03-22
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for design changes to the 9-13 mm stents and delivery systems.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S123
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-03-22
- Decision code
- APPR
- Date received
- 2018-11-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the 9-13 mm stents and delivery systems.