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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 ABLATION CATHETER & 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 NumberS008
Date Received02/12/2007
Decision Date03/16/2007
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 A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY DUAL 8 ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY DUAL 8 ABLATION CATHETER IS INTENDED FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) ABLATION GENERATOR AT A MAXIMUM OF 100 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER). THE GENERATOR IS LIMITED TO 100 WATTS WHEN USED WITH THE THERAPY DUAL 8 ABLATION CATHETERS.
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