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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 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 NumberS005
Date Received08/18/2006
Decision Date10/03/2006
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 ADAPTER CABLE, 1739-W, TO ALLOW THE THERAPY DUAL 8 CATHETER TO BE USED WITH THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR, APPROVED UNDER P990071.
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