|
Device | HeartMate II LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S066 |
Date Received | 02/14/2017 |
Decision Date | 04/11/2017 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the warning statement related to body surface area (BSA) in the HeartMate II LVAS labeling. |