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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 NameATAKR(TM) RFCA SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS004
Date Received08/30/1995
Decision Date09/30/1996
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - software
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.
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