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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.
 
DeviceABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbiomed Cardiovascular, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP900023
Supplement NumberS040
Date Received03/16/2004
Decision Date06/28/2004
Withdrawal Date02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF TWO INFLOW CANNULAE (MALLEABLE 42 FR. AND 32 FR.) TO BE ADDED TO THE CURRENTLY APPROVED CANNULAE USED WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.
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