|
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 | S031 |
Date Received | 07/01/2020 |
Decision Date | 12/17/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update regarding pediatric uses of the device. |
Post-Approval Study | Show Report Schedule and Study Progress |