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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 NumberS004
Date Received08/30/1995
Decision Date09/30/1996
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addtion of a graph showing the relationship of initial atakr power output to temperature set point during the ramp up period in temperature control mode and the addtion of a warning statement rearding proper connection techniqures when utilizing the atakr system with other catheter laboratory equipment.