|
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 | S115 |
Date Received | 10/30/2017 |
Decision Date | 07/26/2018 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This device is indicated for hemodynamic support in patients with advanced, refractory leftventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned. We are pleased to inform you that the PMA supplement is approved. |