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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 NameCARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantSORIN GROUP ITALIA S.R.L
PMA NumberP900060
Date Received09/24/1990
Decision Date09/29/1993
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 93M-0383
Notice Date 11/09/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S029 S030 S032 
S033 S034 S035 S036 S037 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 
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