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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.
 
DeviceMEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP930029
Supplement NumberS021
Date Received12/10/2003
Decision Date02/05/2004
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 A LINE EXTENSION TO THE COMMERCIALLY AVAILABLE RF ENHANCR CATHETER LINE WITH THE CHANGES LIMITED TO A NEW HANDLE DESIGN AND ASSOCIATED PACKAGING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS AND IS INDICATED FOR USE WITH THE MEDTRONIC RF POWER GENERATOR TO DELIVER RF ENERGY FOR INTRACARDIAC ABLATION 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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