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 Endoprosthesis with Heparin Bioactive Surface |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | W.L. GORE & ASSOCIATES,INC 3250 W.KILTIE LANE FLAGSTAFF, AZ 86001 |
PMA Number | P130006 |
Supplement Number | S063 |
Date Received | 11/15/2018 |
Decision Date | 12/13/2018 |
Product Code |
PFV |
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 Implement upgraded equipment and software used for heparin analytical testing. |
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