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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
2375 morse ave.
irvine, CA 92614
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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