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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePOLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBoston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798
PMA NumberP220032
Date Received12/20/2022
Decision Date08/08/2023
Product Code OAE 
Docket Number 23M-3943
Notice Date 09/15/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT04133168
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Boston Scientific Cardiac Cryoablation System using the POLARx Cryoablation Balloon Catheters. The device is indicated for the treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation (PAF). In addition it is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation. The SMARTFREEZE Cryo-Console is intended to be used with POLARx cryoablation balloon catheters only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S003 S001 S002 
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