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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 CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIrvine Biomedical,Inc.(Ibi)
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040042
Supplement NumberS011
Date Received09/19/2007
Decision Date10/19/2007
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  
REROUTING OF ONE SET OF THERMOCOUPLE WIRES AND A MODIFICATION TO THE ACTIVATION WIRE.
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