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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 NumberS058
Date Received10/08/2009
Decision Date01/21/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for reformulation of the hotmelt adhesive that is used in medtronic crdm sterile barrier packages.
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