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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 400 SERIES IPG'S
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS008
Date Received09/24/1998
Decision Date03/12/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic europe s. A. , route de molliau, tolochenaz, switzerland and a final packaging site located at medtronic b. V. , kerkrade, wenckebachstraat 10, 6466, postbus, 1013-6460 ba, kerkrade, the netherlands.
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