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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 COOL PATH ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP060019
Supplement NumberS030
Date Received11/07/2014
Decision Date07/09/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
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