|
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 | S024 |
Date Received | 12/03/2019 |
Decision Date | 12/30/2019 |
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 a revision of the Instructions for Use and Patient Handbook to provide further instructions on the management of electrostatic discharge. |