|
Device | HeartMate 3 Left Ventricular Assist System |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P160054 |
Supplement Number | S008 |
Date Received | 05/03/2018 |
Decision Date | 10/18/2018 |
Product Code |
DSQ |
Docket Number | 18M-3983 |
Notice Date | 10/23/2018 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02224755
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the HeartMate 3 Left Ventricular Assist System. The device is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |