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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.
 
DeviceARCTIC FRONT CARDIAC CRYOABLATION CATHETER
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MS MVS46
MOUNDS VIEW, MN 55112
PMA NumberP100010
Supplement NumberS015
Date Received02/17/2012
Decision Date04/12/2012
Product Code OAE 
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 CATHETER CHANGES TO INCREASE THE UNIFORMITY OF THE DISTAL BALLOON SURFACE TEMPERATURE (INCREASED NUMBER OF REFRIGERANT PORTS ON THE INJECTION TUBE COIL, MORE DISTAL POSITION OF THE INJECTION TUBE, INCREASED REFRIGERANT FLOW ON THE 28MM BALLOON), TO ADD NEW VISUAL MARKER ON THE CATHETER SHAFT AND TO IMPLEMENT ADDITIONAL MINOR CHANGES TO THE DESIGN AND LABELING.
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