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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.
 
DeviceIPULSE CIRCULATORY SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
22 CHERRY HILL DRIVE
DANVERS, MA 01923
PMA NumberP900023
Supplement NumberS047
Date Received11/13/2006
Decision Date12/11/2007
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 IPULSE CIRCULATORY SUPPORT SYSTEM, A UNIT THAT WILL SUPPORT PATIENTS IN NEED OF FULL CIRCULATORY SUPPORT USING THE BVS 5000 BLOOD PUMP OR THE AB5000 VENTRICLE, OR PARTIAL VENTRICULAR ASSIST USING THE APPROVED INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE CONSOLE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IPULSE CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN CONJUNCTION WITH THE ABIOMED AB 5000 VENTRICLE AND THE BVS 5000 BLOOD PUMP.
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