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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.
DeviceFreezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
PMA NumberP020045
Supplement NumberS098
Date Received07/19/2021
Decision Date02/18/2022
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the indication for use statement for the Freezor and Freezor Xtra Cardiac Cryoablation Catheters for use with pediatric patients.