|
Device | MEDTRONIC ACTIVA RC AND PC NEUROSTIMULATORS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S083 |
Date Received | 05/03/2010 |
Decision Date | 06/28/2010 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR FIRMWARE DESIGN CHANGES TO AUTOMATE THE HANDLING OF MOST POR (POWER ON RESET) EVENTS IN THE ¿ACTIVA RC AND ACTIVA PC NEUROSTIMULATOR. |