PMA P160021S035
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS035 Date Received06/08/2022 Decision Date07/05/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P160021
- Supplement
- S035
- Product code
- PRL
- Decision date
- 2022-07-05
- Generic name
- Iliac Covered Stent, Arterial
Current openFDA PMA Record
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160021
- Supplement
- S035
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2022-07-05
- Decision code
- OK30
- Date received
- 2022-06-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of a manufacturing space for the balloon cover assembly process.