Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S286 · decided 2017-09-26
Approval details
- PMA number
- P960009
- Supplement
- S286
- 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
- 2017-07-17
- Decision date
- 2017-09-26
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for minor specification and material changes to the antenna wire and solder composition used in the model 37092 External Antenna, in addition to minor manufacturing changes and minor design changes to the exterior mold.
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