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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceArctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MS MVS46
MOUNDS VIEW, MN 55112
PMA NumberP100010
Supplement NumberS110
Date Received10/30/2020
Decision Date06/18/2021
Product Code OAE 
Docket Number 21M-0690
Notice Date 07/13/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT03118518
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for expanding the indications to include the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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