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Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
St. Jude Medical, Inc.
2375 morse avenue
irvine, CA 92614-6233
PMA NumberP110016
Supplement NumberS008
Date Received04/01/2013
Decision Date12/18/2013
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 13M-1693
Notice Date 01/15/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01408485
Supplement Typepanel track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the therapy cool flex ablation catheter. This device is indicated for use with the compatible irrigation pump and 1500t9-cp 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling