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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS018
Date Received11/04/2002
Decision Date12/17/2002
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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