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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC KAPPA 400 SERIES IPG'S
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS008
Date Received09/24/1998
Decision Date03/12/1999
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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