Activa, Percept and SenSight Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S391 · decided 2021-05-25
Approval details
- PMA number
- P960009
- Supplement
- S391
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Activa, Percept and SenSight Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2020-11-27
- Decision date
- 2021-05-25
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the SenSight Directional Lead System and updates to Model A610 DBS Clinician Programmer Application (CPA) Software to version 3.0.
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