|
Device | HeartMate 3™ Left Ventricular Assist System (LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P160054 |
Supplement Number | S044 |
Date Received | 12/14/2021 |
Decision Date | 01/12/2022 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addendums to Instructions for Use and Patient Handbook for HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II Left Ventricular Assist System (LVAS) |