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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.
 
DeviceIBI CARDIAC ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantIRVINE BIOMEDICAL, INC.
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP040014
Supplement NumberS001
Date Received04/01/2005
Decision Date01/20/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1711-M CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE MEDTRONIC CARDIO RHYTHM ATAKR GENERATOR AS WELL AS FOR THE IBI THERAPY ABLATION CATHETER (4 MM TIP) TO BE USED WITH THE 1713-W CABLE WHICH CONNECTS THE IBI THERAPY ABLATION CATHETER TO THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR.
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