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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceATAKR(TM) RFCA SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMEDTRONIC Inc.
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 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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