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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 NameDEMA IPG; C-SERIES IPG; T-SERIES IPG
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator
Applicant MEDTRONIC INC.
PMA NumberP990001
Supplement NumberS058
Date Received11/23/2009
Decision Date12/22/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to remove a washing process.
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