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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantABIOMED CARDIOVASCULAR, INC.
PMA NumberP900023
Date Received04/06/1990
Decision Date11/20/1992
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 92M-0477
Notice Date 07/02/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S037 S038 
S039 S040 S041 S042 S043 S044 S046 S047 S048 
S049 S050 S051 S052 
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