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U.S. Department of Health and Human Services

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.
 
Trade NameBI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP110016
Supplement NumberS006
Date Received01/24/2013
Decision Date04/18/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Aproval for a modified catheter using a tip electrode with 12 irrigation holes from the currently approved safire blu duo bi-directional ablation catheter with the shaft and handle of the currently approved therapy cool path bi-directional ablation catheter. The device, as modified, will be marketed under the trade name therapy cool path duo bi-directional catheter and 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.
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