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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF GENERATOR
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical,Inc.(Ibi)
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040042
Supplement NumberS033
Date Received11/20/2015
Decision Date02/18/2016
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software fixes and enhancements for the Ampere RF generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the Cool Point Irrigation Pump.
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