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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/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP040014
Supplement NumberS016
Date Received01/18/2011
Decision Date02/17/2011
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENT AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.IMPLEMENTATION OF AN ADDITIONAL TEST SYSTEM FOR ELECTRICAL TESTING.
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