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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 NameCCT.2 CRYOABLATION CONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Name7f freezor xtra cardiac cryoablation catheter & cct.2 cryoablation console
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS014
Date Received12/28/2005
Decision Date04/06/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the footswitch, additional ep connectivity, additional efficiency in verification and validation reporting, and the other minor changes listed on page 2 of the submission.
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