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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.
 
DeviceAUTIMA(TM) MODEL 2251 & MODEL 2600
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP820018
Date Received03/30/1982
Decision Date02/10/1983
Withdrawal Date 06/20/2007
Product Code LWP 
Docket Number 83M-0055
Notice Date 03/11/1983
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S005 S006 S009 S010 S011 S012 S013 S014 S016 S017 
S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 
S031 S032 S033 S034 S035 S036 S039 S040 S041 S042 S043 S044 
S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 
S057 S058 S059 S060 S061 S063 S064 S065 S066 S067 S068 S069 
S070 S071 S074 S075 S073 S072 S076 S077 
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