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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 NameFREEZOR MAX CARDIAC CRYOABLATION CATHETER, ARCTIC FRONT ADVANCED CRYOBALLOON CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Supplement NumberS044
Date Received09/02/2014
Decision Date10/01/2014
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 
Alternate supplier to medtronic cryocath for the electrical cable subassemblies for the arctic front advance/freezor and the electrical umbilical cable.
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