PMA P160021S031
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S031
- Product code
- PRL
- Decision date
- 2021-03-31
- Generic name
- Iliac covered stent, arterial
- Approval order statement
- Changes to the balloon delivery system tubing extrusion and hub bonding processes.
Current openFDA PMA Record#
- Device
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S031
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2021-03-31
- Decision code
- OK30
- Date received
- 2021-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the balloon delivery system tubing extrusion and hub bonding processes.