|
Device | Activa Deep Brain Stimulation Therapy System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S339 |
Date Received | 02/14/2019 |
Decision Date | 03/15/2019 |
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 to correct the value for the electrode surface area used in the charge density calculation from 0.12 cm2 to 0.06 cm2. The erroneous value of 0.12 cm2 is currently used in the calculation to display the charge density warning notification when the Activa CPA is used with an ENS and twist lock cable. |