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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.
 
DeviceSafire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical,Inc.(Ibi)
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040042
Supplement NumberS057
Date Received03/12/2025
Decision Date04/10/2025
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  
an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico
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