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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 VISION SOFTWARE SERIES 4.0
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS017
Date Received02/22/2001
Decision Date03/15/2001
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM DR (MODEL 9960 SOFTWARE), GEMII VR (MODEL 9965 SOFTWARE), AND GEM II DR (MODEL 9964 SOFTWARE) ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.
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