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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 CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS019
Date Received08/07/2007
Decision Date09/24/2007
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications that allows: 1) the ibi-1500t6 and t9 cardiac ablation generators (equipped with temperature monitoring) to be used with the safire bi-directional ablation catheter and 2) the extension cables (previously approved under p960016/s016 for use with the ibi-1500t6) be used with the ibi-1500 t9 rf generator.
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