- Device
- Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S363
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2024-02-05
- Decision code
- APPR
- Date received
- 2023-05-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of the treatment of chronic intractable low back and leg pain without prior back surgery in the Indications for Use statement for the Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, and WaveWriter Alpha Prime SCS System.