|
Device | ABIOMED BVS5000 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 | S052 |
Date Received | 10/06/2011 |
Decision Date | 06/26/2012 |
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 CORRECTION OF THE AB5000 DRIVER FAILURE NOTIFICATION ALARM, ADDITION OF A DELAY CIRCUIT TO THE EXTERNAL AB PORTABLE POWER SUPPLY, AND CORRECTION TO THE IPULSE DRIVER PLENUM SEAL. |