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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 NameKAPPA 400 DR IPG AND KAPPA 400 SR IPG
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS031
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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