|
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 | S025 |
Date Received | 01/28/2020 |
Decision Date | 06/26/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate 3rd Tier yarn supplier to manufacture the vascular graft components for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS). |