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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 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS004
Date Received02/08/1999
Decision Date03/05/1999
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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