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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 Name9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE
Classification Namecardiac ablation percutaneous catheter
Generic Name7f freezor xtra cardiac cryoablation catheter & cct.2 cryoablation console
ApplicantCRYOCATH TECHNOLOGIES, INC.
PMA NumberP020045
Supplement NumberS006
Date Received05/12/2004
Decision Date10/26/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 9f freezor max surgical cardiac cryoablation device, a modification to the freezor xtra cardiac cryoablation system previously approved under p020045/s005. The device is indicated for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias.
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