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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/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Supplement NumberS039
Date Received08/18/2011
Decision Date09/15/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Various changes including the addition of a new micrometer and new equipment for resistance and continuity testing.
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