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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(R) RFCA ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP930029
Supplement NumberS014
Date Received06/28/2000
Decision Date07/31/2000
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE TIP ELECTRODE LENGTH (5 MM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONDUCTR(R) MC-5MM, AND IS INDICATED 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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