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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.
 
DeviceDEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP980049
Date Received12/18/1998
Decision Date09/15/1999
Product Code MRM 
Docket Number 00M-0915
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S064  S063 S024 S004 S005 S008 S018 S078 S079 S080 S065 
S066 S059 S012 S013 S014 S015 S016 S017 S038 S039 S040 S041 
S010 S011 S022 S037 S028 S002 S003 S007 S009 S023 S123 S119 
S120 S121 S122 S001 S061 S062 S019 S020 S021 S029 S030 S031 
S032 S033 S034 S035 S036 S045 S050 S053 S054 S060 S042 S043 
S044 S025 S046 S055 S056 S047 S048 S057 S058 S051 S126 S115 
S116 S117 S118 S125 S124 S129 S134 S139 S137 S142 S143 S146 
S131 S127 S128 S130 S135 S026 S027 S067 S068 S102 S103 S110 
S111 S112 S114 S086 S087 S088 S105 S106 S107 S108 S100 S073 
S074 S104 S089 S109 S069 S070 S081 S006 S090 S091 S092 S093 
S113 S075 S076 S077 S049 S082 S101 S138 S097 S098 S099 S140 
S141 S132 S136 S133 S085 S071 S072 S094 S095 S096 S145 S144 
S083 S147 
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