|
Device | HeartWare HVAD System |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S200 |
Date Received | 05/26/2022 |
Decision Date | 09/08/2022 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01966458
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various updates to the Instructions for Use to add the final clinical results of the post-approval studies entitled Newly Enrolled (HW-PAS-01) Training Program (HeartWare-PAS-02), and Cont F/u of HW004-A ENDURANCE. |