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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.
 
DeviceFREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
Medtronic CryoCath LP
8200 coral sea street
mounds view, MN 55112
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 - manufacturer/sterilizer/packager/supplier
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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