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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.
 
DevicePOLARx FIT Cryoablation Balloon Catheters
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantBoston Scientific Corporation
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP220032
Supplement NumberS007
Date Received07/26/2024
Decision Date08/23/2024
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the addition of a visual inspection step to identify an issue related to field reports of high pressure error messages
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