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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 DA+ C & T SERIES IPGS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
Applicant MEDTRONIC INC.
PMA NumberP990001
Supplement NumberS097
Date Received09/22/2011
Decision Date10/21/2011
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 
Change to upgrade the software version from 1. 5. 1 to 1. 5. 2 on a laser welder at a supplier.
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