Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S339 · decided 2019-03-15
Approval details
- PMA number
- P960009
- Supplement
- S339
- 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
- 2019-02-14
- Decision date
- 2019-03-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to correct the value for the electrode surface area used in the charge density calculation from 0.12 cm2 to 0.06 cm2. The erroneous value of 0.12 cm2 is currently used in the calculation to display the charge density warning notification when the Activa CPA is used with an ENS and twist lock cable.
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510(k) clearances by this applicant
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