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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 NameTHERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION
Classification Namecardiac ablation percutaneous catheter
ApplicantST. JUDE MEDICAL
PMA NumberP110016
Supplement NumberS010
Date Received12/05/2013
Decision Date03/21/2014
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the currently marketed 1500t9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name ampere generator and is indicated for: the ampere generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias.
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