|
Device | MEDTRONIC VISION SOFTWARE |
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 | S009 |
Date Received | 11/30/1999 |
Decision Date | 12/23/1999 |
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 the Medtronic Vision software Model 9952/9952A series 3.0 (to program the Medtronic Kappa 400/DX2 devices) and the Medtronic Vision software Model 9953/9953A series 3.0 (to program the Medtronic Kappa 700/600 devices). The devices are indicated for use with the Medtronic Model 9790 and Model 9790C Programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry. |