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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 CARDIAC ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040014
Supplement NumberS008
Date Received09/04/2008
Decision Date06/17/2009
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42.
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