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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 Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP930029
Supplement NumberS036
Date Received02/29/2012
Decision Date03/23/2012
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Updates to the software used to direct and track manufacturing activities.