- Device
- Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S357
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2023-10-05
- Decision code
- APPR
- Date received
- 2022-12-28
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for paresthesia-based stimulation.