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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, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical,Inc.(Ibi)
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040042
Supplement NumberS052
Date Received10/19/2022
Decision Date11/15/2022
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at CENTERPIECE S. DE R.L. DE C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada #11530, Tijuana, Baja California, Mexico, 22250 for ethylene oxide sterilization activities.
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