|
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 | S009 |
Date Received | 05/04/2018 |
Decision Date | 06/01/2018 |
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 Add an alternative second tier supplier of a component used to manufacture the Sealed Outflow Graft and to add a new cleanroom for manufacturing the graft. |