- Device
- Intellis Spinal Cord Stimulation System (SCS Systems)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S510
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-02-17
- Decision code
- OK30
- Date received
- 2022-01-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the visual inspection requirements of the Intellis flex circuit laser solder joint print specification and process qualification in order to align with the sponsors current Neurostimulator designs including the elimination of the solder joint visual inspection requirements for the Component Side of the flex.