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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 NameARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Supplement NumberS033
Date Received01/09/2014
Decision Date02/07/2014
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to manufacturing equipment and manufacturing equipment software changes supporting a windows 7 operating system upgrade.
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