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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 | S013 |
Date Received | 09/29/2014 |
Decision Date | 10/29/2014 |
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 GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING. |