|
Device | IMPELLA VENTRICULAR SUPPORT SYSTEMS |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S009 |
Date Received | 06/10/2016 |
Decision Date | 08/09/2016 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |