- Device
- Master Restore, Itrel®, Synergy®, IntellisTM Spinal Cord Stimulation Systems, PiscesTM, Specify®, Vectris® Spinal Cord S
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S523
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-09-01
- Decision code
- OK30
- Date received
- 2022-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a manual clean-line with a semi-automatic clean line, at Tegra Medical.