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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 Name7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Name7f freezor xtra cardiac cryoablation catheter & cct.2 cryoablation console
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS012
Date Received10/13/2005
Decision Date11/18/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in both the incoming and final quality inspections from the current method of a random sampling of devices to evaluating 100% of the incoming shafts coil dimensions and performing deflection testing on 100% of the finished shafts.
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