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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.
 
DeviceVITATRON T60 DR AND T20 SR SYSTEMS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP990001
Supplement NumberS015
Date Received06/03/2004
Decision Date07/12/2004
Product Code DXY 
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 VITATRON T60 DR AND T20 SR SYSTEMS, WHICH CONSIST OF THE FOLLOWING: 1) THE VITATRON T60 DR SYSTEM INCLUDES THE VITATRON T60 DR MODEL T60A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1. 2) THE VITATRON T20 SR SYSTEM INCLUDES THE VITATRON T20 SR MODEL T20A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1. NOTE: THE ABOVE REFERENCED APPLICATION SOFTWARE AND DESKTOP WILL BE DISTRIBUTED ON THE MODEL VSE03/VSE04 VERSION 2.0 CD-ROM.
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