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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 AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Supplement NumberS031
Date Received09/11/2013
Decision Date03/19/2014
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the equipment used to perform in process testing of the pressure sensor integrated in the blood detector board, the leak detector wire, and the thermocouples and removal of a redundant upstream testing of the pressure sensor function.
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