|
Device | HeartWare Left Ventricular Assist System |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S129 |
Date Received | 09/17/2018 |
Decision Date | 06/06/2019 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of an alternate semi-automated process for preparing epoxy mixture during the HVAD pump housing assembly. |