Prospera SCS System
FDA premarket approval P210037/S004 · decided 2024-08-23
Approval details
- PMA number
- P210037
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prospera SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2024-01-25
- Decision date
- 2024-08-23
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- the change in manufacturer for the inductive telemetry coil communication unit (CU) component of the Prospera Implantable Pulse Generator (IPG) and External Pulse Generator (EPG).
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