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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 PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS003
Date Received06/12/1998
Decision Date07/14/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Requested a change in the application pattern of the epoxy ara that affixes the device battery tot he insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
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