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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 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS004
Date Received02/08/1999
Decision Date03/05/1999
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the model 6940 capsurefix ventricular/atrial transvenous lead. The device, as modified will be marketed under the trade name model 6940 capsurefix lead and is intended for single long-term use in the right ventricle or right atrium for pacing and sensing.
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