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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARCTIC FRONT CRYOCATHETER SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Date Received03/12/2010
Decision Date12/17/2010
Product Code
OAE[ Registered Establishments with OAE ]
Docket Number 11M-0041
Notice Date 02/01/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00523978
NCT00889681
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval of the arctic front cryocatheter system. The device is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
S020 S021 S023 
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