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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 NumberS006
Date Received09/05/2006
Decision Date01/10/2007
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR 1) THE ADDITION OF THERMISTOR TEMPERATURE SENSOR CATHETERS TO THE THERAPY CATHETER MODEL MIX, 2) THE ADDITION OF A 1763-E COMPATIBLE INTERFACE CABLE TO THE 4MM THERMISTOR ABLATION CATHETER, AND 3) THE ADDITION OF THE 1778-E COMPATIBLE INTERFACE CABLE TO THE 8MM THERMISTOR ABLATION CATHETER.
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