PMA P160021S037
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S037
- Product code
- PRL
- Decision date
- 2023-03-16
- Classification
- Cardiovascular
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Additional analytical test laboratory and approval of a heparin coating related supplier site change.
Current openFDA PMA Record#
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S037
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2023-03-16
- Decision code
- OK30
- Date received
- 2023-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional analytical test laboratory and approval of a heparin coating related supplier site change.