Prospera SCS System, Resilience Surgical Lead, Embrace One
FDA premarket approval P210037/S006 · decided 2025-03-24
Approval details
- PMA number
- P210037
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Prospera SCS System, Resilience Surgical Lead, Embrace One
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2024-05-01
- Decision date
- 2025-03-24
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for changes made to update the Clinician Programmer Application (CP App), Patient Remote Application (PR App), and Neuro Service Center (NSC). Specifically, changes were made to update the Clinician Programmer Application to version 2.9.5 which includes changes such as bug removals, minor improvements, default value for stimulation mode has been changed to Multiphase, corrected ViStim formula to allow intended therapy programming range, changed lower limit for electrode failure from 2
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