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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 NameVITATRON T60 DR AND T20 SR SYSTEMS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
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 - specifications
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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