|
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 | S020 |
Date Received | 12/06/1996 |
Decision Date | 12/31/1996 |
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 CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM. |