|
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 | S020 |
Date Received | 05/01/2013 |
Decision Date | 12/20/2013 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW MONITOR FOR THE HEARTWARE VENTRICULAR ASSIST SYSTEM. THE MONITOR WILL BE MANUFACTURED BY XPLORE TECHNOLOGIES, AUSTIN, TX. |