|
Device | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
Generic Name | Iliac covered stent, arterial |
Applicant | W. L. Gore & Associates, Inc. 3250 WEST KILTIE LANE FLAGSTAFF, AZ 86005 |
PMA Number | P160021 |
Supplement Number | S037 |
Date Received | 02/16/2023 |
Decision Date | 03/16/2023 |
Product Code |
PRL |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Additional analytical test laboratory and approval of a heparin coating related supplier site change. |