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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 and Freezor MAX Cardiac CryoAblation
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic Cryocath, LP
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP020045
Supplement NumberS086
Date Received02/07/2018
Decision Date04/17/2018
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of a change to the product requirement specification documents related to the external surface of the effective length of the catheter, as well as associated changes to the manufacturing process and process planning matrix.
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