|
Device | HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S023 |
Date Received | 06/03/2013 |
Decision Date | 08/30/2013 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HEARTWARE® WAIST PACK AND THE HEARTWARE® SHOULDER PACK. |