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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameIBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP060019
Date Received05/30/2006
Decision Date03/16/2007
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 07M-0108
Notice Date 03/26/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
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 S029 
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