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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS044
Date Received01/05/2006
Decision Date07/07/2006
Withdrawal Date 02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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