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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 Namecardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
PMA NumberP020045
Supplement NumberS006
Date Received05/10/2004
Decision Date10/26/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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