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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.
 
DeviceVITATRON T60 DR AND T20 SR SYSTEMS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP990001
Supplement NumberS015
Date Received06/03/2004
Decision Date07/12/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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