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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 Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP060019
Supplement NumberS022
Date Received07/10/2012
Decision Date09/07/2012
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DESIGN MODIFICATION TO THE BOND BETWEEN THAT CATHETER SHAFT AND THE EXTENSION TUBING. SPECIFICALLY, YOU PROPOSE TO CHANGE THE ADHESIVE FROM LOCTITE TO URETHANE AND TO MODIFY THE CONTACT HOLE FROM A CIRCULAR TO AN OCTAGONAL SHAPE.
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