|
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 | S004 |
Date Received | 08/27/1998 |
Decision Date | 09/22/1998 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for Version .13 firmware which incorporates Automatic Polarity configuration (APC). |