|
Device | HeartMate II Left Ventricular Assist System (LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S096 |
Date Received | 10/31/2023 |
Decision Date | 12/23/2023 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the change of obsoleted components on the printed circuit board assembly (PCBA) used in the HeartMate Mobile Power Unit (MPU). |