- Device
- Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S331
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-01-24
- Decision code
- APPR
- Date received
- 2019-10-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updating the Clinician Programmer (CP) computer to Surface Pro (SP6) with Windows 10 and for minor installation and labeling updates to the Bionic Navigator software used with the Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Cord Stimulator (SCS) Systems.