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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 AB5000 CIRCULATORY SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbiomed Cardiovascular, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP900023
Supplement NumberS042
Date Received12/22/2004
Decision Date03/23/2005
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 A CHANGE TO ONLY THE AB5000 CIRCULATORY SUPPORT SYSTEM THAT WILL ALLOW THE USER AN ALTERNATE MEANS OF REDUCING BLOOD FLOW DURING WEANING BY ADJUSTING THE LEVEL OF VACUUM APPLIED TO THE AB5000 BLOOD PUMP.
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