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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 ADVANCE CARDIAC 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 NumberS046
Date Received12/08/2014
Decision Date02/27/2015
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TWO NEW MODELS TO BE ADDED TO THE ARCTIC FRONT FAMILY OF CARDIAC CRYOABLATION CATHETERS: ARCTIC FRONT ADVANCE ST CARDIAC CRYOABLATION CATHETERS MODELS 2AFAST23 AND 2AFAST28.
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