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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 NameHANCOCK MODIFIED ORIFICE BIOPROSTHESIS
Classification Nameheart-valve, non-allograft tissue
Generic Nameheart valve
ApplicantMEDTRONIC HEART VALVES
PMA NumberP790007
Date Received02/21/1979
Decision Date11/15/1979
Product Code
LWR[ Registered Establishments with LWR ]
Notice Date 08/08/1980
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Supplements: S001 S002 S003 S004 S005 S007 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 
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