|
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 | S026 |
Date Received | 03/16/2020 |
Decision Date | 04/09/2020 |
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 Qualify an alternate sub-supplier for the polyester raw material used in the manufacture of the HeartMate II Apical Sewing Ring and Percutaneous Cable as well as the HeartMate 3 Percutaneous Cable. |