|
Device | HeartWare® Ventricular Assist System |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S197 |
Date Received | 04/18/2022 |
Decision Date | 05/10/2022 |
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 a holding fixture during assembly of the battery pack, change in the tape used during assembly, and revision of the final inspection procedure. |