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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 CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040014
Supplement NumberS011
Date Received07/30/2009
Decision Date08/28/2009
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE PROXIMAL COMPONENT OF THE ABLATION CATHETERS.
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