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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 MAX CARDIAC CRYOABLATION CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMEDTRONIC CRYOCATH LP
PMA NumberP100010
Supplement NumberS012
Date Received09/08/2011
Decision Date10/07/2011
Product Code
OAE[ Registered Establishments with OAE ]
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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