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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Date Received05/11/1998
Decision Date10/09/1998
Product Code LWS 
Docket Number 98M-0907
Notice Date 12/07/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Medtronic(R) Model 7271 GEM(TM) DR Dual Chamber Implantable Cardioverter Defibrillator System with Mdoel 9960 (GEM(TM) DR) Application Software, Medtronic(R) Model 6940 CapSureFix(R) Lead and Model 9466 Patient Magnet. This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (Note: the clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies have not been conducted.)
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