|
Device | 42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF |
Generic Name | Ventricular (assist) bypass |
Applicant | ABIOMED CARDIOVASCULAR, INC. 22 CHERRY HILL DRIVE DANVERS, MA 01923 |
PMA Number | P900023 |
Supplement Number | S044 |
Date Received | 01/05/2006 |
Decision Date | 07/07/2006 |
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 FOR DESIGN CHANGES TO INTEGRATE THE PREVIOUSLY APPROVED 42 FR. VENTRICULAR/ATRIAL CANNULA AND PREVIOUSLY APPROVED SEWING CUFF ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 42 FR. VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF AND IS INDICATED FOR USE WITH THE BVS 5000 BIVENTRICULAR SUPPORT SYSTEM AND WITH THE AB5000 CIRCULATORY SUPPORT SYSTEM. |