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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES,
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Supplement NumberS063
Date Received09/15/2014
Decision Date10/15/2014
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to packaging/labeling systems used to trigger label printing and facilitate selection of product determination for packaging.
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