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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.
 
DeviceWEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
Generic Namewearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Date Received05/04/2001
Decision Date12/18/2001
Product Code MVK 
Docket Number 02M-0145
Notice Date 04/12/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE WCD 2000 SYSTEM. THIS DEVICE IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND EITHER ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 S080 S081 S083 S084 S085 
S086 S087 S088 S089 S090 S091 S092 S095 S097 S098 S099 S100 
S101 S102 S103 S104 S105 S106 S107 S108 S110 S111 S112 S113 
S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 
S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S137 S138 
S139 S140 S141 S142 S143 S144 S145 S146 S147 S148 S149 S150 
S151 S152 S153 S154 S155 S156 S157 S159 
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