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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: S030  S047 S067 S068 S069 S070 S071 S039 S059 S045 S046 
S055 S056 S050 S051 S052 S053 S062 S035 S008 S019 S005 S004 
S007 S021 S009 S002 S003 S025 S072 S074 S075 S076 S087 S088 
S089 S090 S091 S095 S026 S028 S029 S027 S031 S044 S048 S057 
S063 S064 S065 S040 S041 S042 S060 S036 S054 S032 S033 S034 
S058 S066 S049 S037 S038 S061 S010 S006 S011 S012 S022 S023 
S024 S001 S013 S014 S015 S016 S017 S018 S020 S084 S085 S073 
S098 S077 S078 S079 S092 S086 S080 S081 S083 S097 S108 S100 
S101 S102 S103 S117 S118 S123 S124 S125 S132 S133 S134 S135 
S137 S138 S116 S142 S143 S128 S165 S153 S161 S154 S155 S167 
S168 S169 S099 S106 S107 S104 S105 S111 S112 S139 S140 S113 
S114 S115 S126 S127 S129 S130 S131 S144 S119 S120 S121 S122 
S110 S141 S163 S157 S160 S150 S151 S164 S147 S148 S149 S166 
S145 S146 S158 S159 S162 S156 S152 S173 S174 S175 S176 S177 
S170 S171 S172 
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