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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/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM
Classification Namecardiac ablation percutaneous catheter
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS026
Date Received03/09/2009
Decision Date07/07/2009
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new cryoablation console which includes changes to the hardware, software, user interface, and mechanical circuit for the 7f freezor cardiac cryoablation catheter and cryoconsole, 7f freezor xtra surgical catheter and cryoconsole, and 9f freezor max surgical catheter and cryoconsole. The new cryoablation console device, as modified, will be marketed under the trade name cryoconsole to be used with the aforementioned catheters.
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