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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, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical,Inc.(Ibi)
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040042
Supplement NumberS040
Date Received02/05/2018
Decision Date03/06/2018
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Alternative Electrical Safety Test for the Ampere Generator, Ampere Remote Control and TactiSys Quartz Equipment.
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