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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 NameACTIVITRAX MODELS 8400, 8402, 8403
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse g
Applicant MEDTRONIC INC.
PMA NumberP850051
Date Received07/19/1985
Decision Date06/10/1986
Product Code
LWO[ Registered Establishments with LWO ]
Docket Number 86M-0266
Notice Date 07/11/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S020 S021 
S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 
S034 S035 S036 S037 S038 S039 
S040 S041 S043 S044 S045 S046 
S048 S049 S050 S051 S052 S054 
S055 S056 S057 S060 S061 S062 
S064 S065 S066 S067 S068 S069 
S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 
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