|
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 | S092 |
Date Received | 04/14/2023 |
Decision Date | 04/29/2023 |
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 Implement a supplier facility relocation for the User Interface (UI) Membrane component of the HeartMate II System Controller and HeartMate 3 System Controller. |