Activia Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S365 · decided 2020-06-25
Approval details
- PMA number
- P960009
- Supplement
- S365
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Activia Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2019-12-02
- Decision date
- 2020-06-25
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the new WR9200 Wireless Recharger Subsystem and associated labeling. The new WR9200 Wireless Recharger Subsystem is intended to recharge the Activa RC implantable neurostimulator (INS) for Deep Brain Stimulation Therapy and the following Restore INSs for Spinal Cord Stimulation Therapy: RestoreUltra; RestoreUltra SureScan MRI; RestoreSensor; and RestoreSensor SureScan MRI.
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