|
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 | S020 |
Date Received | 03/12/2019 |
Decision Date | 10/02/2019 |
Product Code |
PRL |
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. |