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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 NameENDOTAK LEAD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
PMA NumberP910073
Date Received12/19/1991
Decision Date08/26/1993
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 94M-0064
Notice Date 04/19/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S010 S011 
S013 S014 S015 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 S053 S054 S055 S056 S057 
S058 S059 S060 S061 S062 S064 S065 S067 S068 
S072 S073 S074 S075 S076 S077 S078 S079 S081 
S082 S083 S084 S085 S086 S089 S090 S091 S092 
S093 S094 S095 S096 S097 S098 S099 S100 S101 
S102 S103 S104 S105 S106 S107 S108 S109 S110 
S111 S112 S113 S114 S115 S116 S117 S118 S120 
S121 
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