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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 NameSAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantST. JUDE MEDICAL
PMA NumberP110016
Supplement NumberS007
Date Received03/07/2013
Decision Date08/29/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Clinical Trials NCT01401361
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the safire duo/cool path duo ablation catheters, verisense enabled, ibi 1500t9-cp v1. 6 cardiac ablation generator and verisense system. This device is indicated for use with the compatible irrigation pump and the1500t9-cp radiofrequency (rf) generator at a maximum of 50 watts. The catheters are intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
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