PMA P040037S127
- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S127
- Product code
- NIP
- Decision date
- 2019-03-06
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Update raw material specifications and non-compendial test methods.
Current openFDA PMA Record#
- Device
- GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S127
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2019-03-06
- Decision code
- OK30
- Date received
- 2019-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update raw material specifications and non-compendial test methods.