|
Device | ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | ABIOMED CARDIOVASCULAR, INC. 22 CHERRY HILL DRIVE DANVERS, MA 01923 |
PMA Number | P900023 |
Supplement Number | S026 |
Date Received | 01/02/1998 |
Decision Date | 02/02/1998 |
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 to change the current BVS battery to a Hawker Genesis HrD 13 Ah battery, Model G12V13Ah10EP. |