Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
FDA premarket approval P030017/S363 · decided 2024-02-05
Approval details
- PMA number
- P030017
- Supplement
- S363
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2023-05-30
- Decision date
- 2024-02-05
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- 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.
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