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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 NameMEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS020
Date Received02/14/2002
Decision Date02/26/2002
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate facilities for the manufacturing, packaging and sterilization of the medtronic kappa 900/800 series pulse generator products: medtronic bv, kerkrade, the netherlands and medtronic europe s. A. , tolochanez, switzerland.
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