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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.
 
DeviceIBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP060019
Date Received05/30/2006
Decision Date03/16/2007
Product Code OAD 
Docket Number 07M-0108
Notice Date 03/26/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE THERAPY COOL PATH ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY COOL PATH ABLATION CATHETER IS INTENDED FOR USE WITH A COMPATIBLE EXTERNAL INFUSION PUMP AND THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER). THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY COOL PATH CATHETERS. A COMPATIBLE EXTERNAL INFUSION PUMP MUST BE CONNECTED WHEN USED WITH THERAPY COOL PATH CATHETERS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S013 
S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 
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