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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 AND IBI-1500T6 CARDIAC ABLATION GENERATOR
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP040042
Supplement NumberS004
Date Received08/01/2006
Decision Date09/20/2006
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN EXTENDER MODULE TO THE ACCESSORY LIST FOR THE GENERATOR. THE EXTENDER MODULE WILL ALLOW THE USER TO PLACE THE GENERATOR UP TO AN ADDITIONAL TWENTY FEET FROM THE PATIENTS.
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