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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
Generic NameVentricular (assist) bypass
ApplicantAbiomed Cardiovascular, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP900023
Date Received04/06/1990
Decision Date11/20/1992
Withdrawal Date02/01/2018
Product Code DSQ 
Docket Number 92M-0477
Notice Date 07/02/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S020 S021 S022  S042 S043 S026 S027 S037 S001 S002 S004 
S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S030 
S031 S032 S039 S040 S041 S016 S017 S052 S048 S049 S050 S035 
S028 S029 S044 S034 S033 S023 S024 S025 S038 S046 S047 S051 
S018 S019 
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