|
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 | S041 |
Date Received | 03/26/2004 |
Decision Date | 06/28/2004 |
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 THE SEWING CUFF FOR CANNULA PLACEMENT FOR THE USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM. |