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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 CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantIrvine Biomedical, Inc.
2375 Morse Ave.
Irvine, CA 92614
PMA NumberP060019
Supplement NumberS028
Date Received04/30/2014
Decision Date04/09/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A ST. JUDE MEDICAL MANUFACTURING SITE LOCATED AT ST. PAUL, MN TO SERVICE AND REPAIR THE 1500T SERIES RF GENERATORS.
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