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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.
 
DeviceMEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Date Received06/29/1979
Decision Date12/23/1981
Withdrawal Date 12/23/2011
Product Code LWQ 
Docket Number 82M-0003
Notice Date 01/29/1982
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S012 S013 
S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 
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