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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.
 
DeviceNitron CryoConsole and Nitron Remote
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS105
Date Received07/07/2023
Decision Date02/01/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a new iteration of the CryoConsole, the Nitron CryoConsole and Nitron Remote, which is a component of the Cryoablation system
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