Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S332 · decided 2019-02-12
Approval details
- PMA number
- P960009
- Supplement
- S332
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2018-11-21
- Decision date
- 2019-02-12
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Maintenance Release 1 Update to the Model A610 Activa DBS Clinician Programmer Application which updated the impedance measurement workflow, enabled interleaving programming in both hemispheres, and updated reports.
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