|
Device | ABIOMED(R) BVS 5000(R) 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 | S033 |
Date Received | 05/10/2000 |
Decision Date | 06/22/2000 |
Withdrawal Date
|
02/01/2018 |
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 36 FRENCH POLYURETHANE ARTERIAL CANNULA WITH A STAINLESS STEEL WIRE REINFORCED COIL AND A 10 MM HEMASHIELD(R) GRAFT. |