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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 NameMEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP900061
Date Received09/28/1990
Decision Date02/11/1993
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 93M-0083
Notice Date 04/05/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 S087 S088 S089 S090 S091 S092 S093 S094 
S096 S097 S098 S099 S100 S101 S102 S103 S104 
S105 S106 S107 S108 S109 S110 S111 S112 S113 
S114 S115 S117 S118 S119 S120 S121 S122 S123 
S124 S125 S126 S127 S128 S129 S130 
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