PMA P160021S034
- Device
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.3250 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP160021 Supplement NumberS034 Date Received02/11/2022 Decision Date03/18/2022 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
- S034
- Product code
- PRL
- Decision date
- 2022-03-18
- 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
- S034
- Product code
- PRL
- Generic name
- Iliac covered stent, arterial
- Decision date
- 2022-03-18
- Decision code
- OK30
- Date received
- 2022-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New test article preparation equipment for heparin activity and heparin concentration testing.