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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 CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Supplement NumberS035
Date Received10/20/2010
Decision Date12/15/2010
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of a catheter configuration file for the arctic front cardiac cryoablation catheter to the cryoconsole and related modifications to the cryoconsole manual.
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