Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S040 |
Date Received | 06/13/2023 |
Decision Date | 07/13/2023 |
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 Use of two new heparin coating machines. |
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