|
Device | HeartWare HVAD System |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S139 |
Date Received | 04/25/2019 |
Decision Date | 10/21/2019 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the Instructions for Use to include findings from the Bridge-to-Transplant PAS03 study and data from longer term follow-up of ENDURANCE Supplemental study subjects. |