PMA P040037S158
- Device
- GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S158
- Product code
- NIP
- Decision date
- 2023-03-16
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Additional ovens used for delivery system component manufacturing at a supplier.
Current openFDA PMA Record#
- Device
- GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P040037
- Supplement
- S158
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2023-03-16
- Decision code
- OK30
- Date received
- 2023-03-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional ovens used for delivery system component manufacturing at a supplier.