- Device
- Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S333
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-03-17
- Decision code
- OK30
- Date received
- 2020-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate EO sterilization cycle and upgraded sterilization equipment to sterilize all sterile products and accessories of the SCS Systems.