Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems
- PMA Number
- P030017
- Supplement Number
- S389
- 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
- December 10, 2025
- Date Received
- September 25, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for the extension of shelf-life from 6 months to 15 months for the Hydrogen Silsesquioxane material utilized in the insulation layer production of a component within the printed circuit board assembly of Implantable Pulse Generator (IPG) and of External Trial Stimulator (ETS) Kits in the WaveWriter Alpha Prime Spinal Cord Stimulation and Vercise Genus Deep Brain Stimulation Systems. The component, manufactured by a third-party supplier, is not patient-contacting and is fully encapsulated within the IPG and ETS.
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 |