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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 BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS037
Date Received07/01/2002
Decision Date04/28/2003
Withdrawal Date 02/01/2018
Product Code DSQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM. THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.
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