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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.
 
DeviceRF CONTACTR ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP930029
Supplement NumberS015
Date Received08/06/2001
Decision Date10/09/2001
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 ADDITION OF A SECONDARY DISTAL CURVE FEATURE CAPABLE OF DEFLECTIONS OF UP TO 135 DEGREES AND THE REMOVAL OF THE VARIABLE CURVE REACH FEATURE AND OTHER MINOR DESIGN CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RF CONTACTR ABLATION CATHETER AND IS INDICATED FOR USE WITH A MEDTRONIC RF POWER GENERATOR FOR THE INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
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