|
Device | 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 | S029 |
Date Received | 04/02/1999 |
Decision Date | 05/19/1999 |
Withdrawal Date
|
02/01/2018 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device. |