Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- Prospera SCS System, Resilience Surgical Lead, Embrace One
- PMA Number
- P210037
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- LGW
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 24, 2025
- Date Received
- May 1, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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 200 Ohm to 100 Ohm, and reduction of Clinician Programmer Application startup time. Patient Remote Application to version 2.9.5 which includes changes such as bug removals, minor improvements, and reduced startup time for PR App. Neuro Service Center updated to 1.5.89 which includes changes such as bug fixes and minor improvements.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | FDA class 3 | Unknown |