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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.
 
DeviceARCTIC FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
Medtronic CryoCath LP
8200 coral sea street
ms mvs46
mounds view, MN 55112
PMA NumberP100010
Supplement NumberS035
Date Received03/05/2014
Decision Date04/03/2014
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Updates to the manufacturing steps and fixtures at manufacturing station p09 y block to shaft assembly used in the manufacture of the arctic front and arctic frontadvance catheters.
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