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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.
 
Device7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Date Received10/23/2002
Decision Date04/17/2003
Product Code LPB 
Docket Number 05M-0475
Notice Date 11/28/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM. THE DEVICE IS INDICATED FOR THE CRYOABLATION OF THE CONDUCTING TISSUES OF THE HEART IN THE TREATMENT OF PATIENTS WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S017 S019 S021 S022 S025 S026 S027 S028 
S029 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 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 S080 S081 
S082 S083 S084 S085 S086 S087 S088 S089 S090 S092 S093 S094 
S095 S096 S097 S098 S099 S100 S101 S102 S103 S104 S105 S106 
S107 S108 S109 
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