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Device | MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P970012 |
Supplement Number | S003 |
Date Received | 06/12/1998 |
Decision Date | 07/14/1998 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |