Prospera SCS System, Resilience Surgical Lead
FDA premarket approval P210037/S003 · decided 2024-03-13
Approval details
- PMA number
- P210037
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prospera SCS System, Resilience Surgical Lead
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2023-12-14
- Decision date
- 2024-03-13
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for an updated Power Delivery Controller software change to bypass the gas gauge within the charger and instead determine internal battery State of Charge based on measurements from the actual battery voltage via the battery charger integrated circuit
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