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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 NameVARIOUS FAMILIES OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS080
Date Received10/19/2007
Decision Date11/16/2007
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 
Addition of a paperless chart recorder to the sterilization operations at the tolochenaz, switzerland manufacturing facility.
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