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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
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC, INC.
PMA NumberP990001
Supplement NumberS114
Date Received05/30/2013
Decision Date06/27/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the battery iodine fill stations for selected low power batteries.
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