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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
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP990001
Supplement NumberS028
Date Received02/26/2007
Decision Date07/10/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the vitatron family application software models that support the diva, dema and selection afm 902 devices (vsc02 version 9. 1 sr1), c-series devices a1 models (vsf04 version 1. 3), c-series devices a3 models (vsf12 version 1. 2, and t-series devices (vsf08 version 1. 6). The modifications will update the emi behavior of your device, correct the issue of da+ inhibition of pacing below the programmed threshold, identify to the user inaccurate coulomb counts, allow the application suite to be split into several application packages, and minor software enhancements.
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