Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S284 · decided 2017-09-01
Approval details
- PMA number
- P960009
- Supplement
- S284
- 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
- 2017-06-07
- Decision date
- 2017-09-01
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a minor design change (lowering values of resistances R54 and R56 in the analog board of the INSR) to the Implantable Neurostimulator Recharger (INSR) used in the Restore Spinal Cord Stimulation and Activa Deep Brain Stimulation therapy systems.
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