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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.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
PMA NumberP100010
Supplement NumberS015
Date Received02/17/2012
Decision Date04/12/2012
Product Code
OAE[ Registered Establishments with OAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for catheter changes to increase the uniformity of the distal balloon surface temperature (increased number of refrigerant ports on the injection tube coil, more distal position of the injection tube, increased refrigerant flow on the 28mm balloon), to add new visual marker on the catheter shaft and to implement additional minor changes to the design and labeling.