Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S363 · decided 2020-01-29
Approval details
- PMA number
- P960009
- Supplement
- S363
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2019-11-20
- Decision date
- 2020-01-29
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for labeling updates to the Deep Brain Stimulation (DBS) Therapy System.
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