- Device
- Precision Spinal Cord Stimulator Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S346
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-06-02
- Decision code
- OK30
- Date received
- 2021-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to clear the manufacturing data logs created during the Printed Circuit Board assembly (PCBA) manufacturing process at the Boston Scientific Clonmel manufacturing site