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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, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantIRVINE BIOMEDICAL, INC.
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP060019
Supplement NumberS034
Date Received09/23/2015
Decision Date10/21/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
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