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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
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantSt. Jude Medical, Inc.
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/material
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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