Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock
FDA premarket approval P210037/S005 · decided 2024-06-13
Approval details
- PMA number
- P210037
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2024-02-23
- Decision date
- 2024-06-13
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- for an update to the factory file used during the final manufacturing step to configure the BLE transmission power to +4 dBm.
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