|
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 | S017 |
Date Received | 02/06/2019 |
Decision Date | 06/04/2019 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update to include instructions on implantation procedure using surgical techniques other than full median sternotomy. |