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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 CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE
Classification Namecardiac ablation percutaneous catheter
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP020045
Supplement NumberS040
Date Received09/08/2011
Decision Date10/07/2011
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to reduce adhesive curing time for ecg rings and the tip electrode.
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