Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
FDA premarket approval P960009/S424 · decided 2022-06-15
Approval details
- PMA number
- P960009
- Supplement
- S424
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2022-03-18
- Decision date
- 2022-06-15
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes to the Medtronic Model A610 DBS Clinician Programmer Application version 3.0. The changes consist of a fix to a software defect subject to field corrective action, as well as fixes to other minor defects in the A610 application.
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