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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 NameCOSMOS(TM) SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator, programmer, & module
ApplicantBOSTON SCIENTIFIC
PMA NumberP830026
Date Received06/06/1983
Decision Date03/23/1984
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 84M-0130
Notice Date 04/25/1984
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S051 S052 S053 S054 S055 S056 S057 
S058 S059 S060 S061 S062 S063 S064 S065 S066 
S067 S069 S070 S071 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 
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