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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameARCTIC FRONT/ ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER FAMILIES OF DEVICES
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant MEDTRONIC INC.
PMA NumberP100010
Supplement NumberS047
Date Received01/29/2015
Decision Date04/01/2015
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to device accessories in order to comply with iec 60601-1 3rd edition and/or to align with company policy.
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