|
Device | ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | ABIOMED CARDIOVASCULAR, INC. 22 CHERRY HILL DRIVE DANVERS, MA 01923 |
PMA Number | P900023 |
Supplement Number | S043 |
Date Received | 01/18/2005 |
Decision Date | 03/11/2005 |
Withdrawal Date
|
02/01/2018 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF FOUR NEW INFLOW CANNULAE (32/42 FR APICAL CANNULA WITH SIDE HOLES AND 32/42 FR APICAL CANNULA WITHOUT SIDE HOLES) FOR USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM. |