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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 MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE
Generic NameCardiac ablation percutaneous catheter
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP930029
Supplement NumberS018
Date Received11/04/2002
Decision Date12/17/2002
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 CABLE THAT WILL ALLOW A MEDTRONIC RADIO-FREQUENCY ABLATION CATHETER TO FUNCTION AS A DIAGNOSTIC CATHETER BY PROVIDING CONNECTIVITY TO AN EP RECORDING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE AND IS INDICATED FOR USE DURING DIAGNOSTIC ELECTROPHYSIOLOGIC STUDIES IN CONJUNCTION WITH MEDTRONIC ELECTRODE CATHETERS. THE CABLE IS USED DURING ELECTROPHYSIOLOGY STUDIES TO CONNECT THE ELECTRODE CATHETER TO THE ECG RECORDING/ STIMULATION EQUIPMENT.
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