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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 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP040042
Supplement NumberS027
Date Received03/03/2014
Decision Date04/28/2014
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THEFIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
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