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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.
 
DevicePHYLAX AV ICD SYSTEM
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP000009
Date Received02/14/2000
Decision Date09/29/2000
Product Code MRM 
Docket Number 01M-0042
Notice Date 01/23/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PHYLAX AV ICD SYSTEM INCLUDING THE PULSE GENERATOR, MODEL NUMBER 122 382 AND PHYLAX AV SOFTWARE CARTRIDGE SWM 1000/I-GAV.2.U, MODEL NUMBER 128 814. THE DEVICE IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OR MORE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY A LOSS OF CONSCIOUSNESS DUE TO A VENTRICULAR TACHYARRHYTHMIA 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT) NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS ID NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES FOR THIS INDICATION HAVE NOT BEEN CONDUCTED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S046 S047  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 S038 S039 S040 S041 S042 S043 S045 S048 S049 
S050 S051 S052 S054 S055 S056 S057 S058 S059 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S084 S085 S086 S087 S088 
S089 S090 S091 S092 S093 S094 S097 S098 S099 S100 S101 S102 
S103 S104 S105 S106 S109 
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