|
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 | S034 |
Date Received | 02/19/2021 |
Decision Date | 03/21/2021 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of 5 alternate components from alternate second tier suppliers for the HeartMate 3 System Controller PCBAs, one of which is a shared component with the HeartMate II System Controller PCBA. |