- Device
- Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
- Applicant
- Biotronik Nro, Inc.
- PMA number
- P210037
- Supplement
- S012
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-05-14
- Decision code
- APPR
- Date received
- 2025-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval of a 20-in length version of the approved Tunnelling Tool (an accessory), with updated packaging, to the Prospera SCS System product family