- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S337
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-05-15
- Decision code
- OK30
- Date received
- 2020-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the Printed Circuit Board Assembly inspections for the Implantable Pulse Generators of the Precision Spectra System, Spectra Wave Writer System, Precision Novi System, Precision Montage and Precision Montage MRI Systems.