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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 CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St., Ms Mv S46
Mounds View, MN 55112
PMA NumberP100010
Supplement NumberS025
Date Received04/26/2013
Decision Date12/12/2013
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE IMPLEMENTATION OF AN ALTERNATIVE PROCEDURE INVOLVING THE INFLATION AND DEFLATION OF BALLOONS CONTAINED IN THE DEVICE DURING THE MANUFACTURING PROCESS.
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