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 and 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 | S047 |
Date Received | 12/05/2017 |
Decision Date | 12/28/2017 |
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 | No |
Approval Order Statement Implementation of an alternate resin, supplied by an alternate supplier, in the manufacture of radiopaque marker components of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface. |
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