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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 Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor
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 NumberS145
Date Received03/01/2024
Decision Date03/29/2024
Product Code OAE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
minor manufacturing changes to the Arctic Front Advance (AFA) (2AF234 and 2AF284), Arctic Front Advance Pro (AFA Pro) (AFAPRO23 and AFAPRO28), Freezor (207F1, 207F3, 207F5), Freezor Xtra (217F1, 217F3, 217F5) and Freezor MAX (209F3 and 209F5) cryoablation catheters
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