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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 C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP990001
Supplement NumberS110
Date Received03/11/2013
Decision Date04/04/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to lot release testing and acceptance of device components.
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