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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 NameIMPLANTABLE PULSE GENERATORS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS092
Date Received04/14/2008
Decision Date05/14/2008
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 the workstation used to weld the case-to-cover seam joint on batteries when manufacturing the at500 ipg model at501.
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