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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.
 
DeviceARCTIC FRONT CRYOCATHETER SYSTEM
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MS MVS46
MOUNDS VIEW, MN 55112
PMA NumberP100010
Date Received03/12/2010
Decision Date12/17/2010
Product Code OAE 
Docket Number 11M-0041
Notice Date 02/01/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00523978
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE ARCTIC FRONT CRYOCATHETER SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 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 S043 S044 S045 S046 S047 S048 
S050 S051 S052 S053 S054 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 S082 S083 S084 S085 S086 
S087 S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 
S099 S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 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 S136 S137 S138 S139 S140 S141 S142 S143 S144 S145 S146 
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