|
Device | HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P160054 |
Supplement Number | S015 |
Date Received | 11/19/2018 |
Decision Date | 01/18/2019 |
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 Approval of the protocols for the post-approval studies protocol. |