Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S333 · decided 2019-07-03
Approval details
- PMA number
- P960009
- Supplement
- S333
- Supplement type
- Normal 180 Day Track
- 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
- 2018-11-23
- Decision date
- 2019-07-03
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Model A620 Activa DBS Patient Programmer Application.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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