|
Device | GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 FLAGSTAFF, AZ 86002-0500 |
PMA Number | P040037 |
Supplement Number | S130 |
Date Received | 03/12/2019 |
Decision Date | 10/02/2019 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to implement changes to your divisional bacterial endotoxin test parameters using the Limulus Amebocyte Lysate test methodology. |