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 Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor
- PMA Number
- P030017
- Supplement Number
- S374
- 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 18, 2025
- Date Received
- April 2, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for 1) labeling updates to the WaveWriter Alpha Spinal Cord Stimulator (SCS) MRI Safety Guidelines to allow for Bl+rms limits to be set as the primary limiting condition for RF power, 2) a labeling update to the MRI Safety Guidelines and Precision Adapter M8 Instructions for Use to add the Medtronic Specify SureScan MRI Leads to the list of leads compatible with the BSN M8 Adapter as part of the WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, and 3) the WaveWriter Alpha SCS Mixed System using the Medtronic Specify SureScan leads will be labeled as MRI scan eligible.
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 |