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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 DEVICES
Classification Namecardiac ablation percutaneous catheter
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS021
Date Received01/09/2007
Decision Date04/18/2007
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the leak detection system in the freezor catheter and freezor xtra devices from a single bare stainless steel wire to a duplex insulated wire made of two electrodes.
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