- Device
- Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Noviâ„¢
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S335
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-04-24
- Decision code
- OK30
- Date received
- 2020-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an additional ethylene oxide (EO) sterilization chamber and associated sterilization process located at Boston Scientific Dorado Manufacturing site (BSC-DOR).