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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 RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.
Generic NameCardiac ablation percutaneous catheter
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP930029
Supplement NumberS048
Date Received12/23/2014
Decision Date03/05/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO LABELING AND PACKAGING FOR SPECIFIC ACCESSORIES (I.E., CABLES AND FOOT SWITCH) USED WITH THE MEDTRONIC ATAKR RFCA SYSTEMS.
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