- Device
- Restore, Itrel, and Synergy Spinal Cord Stimulation Systems, Pisces, Resume, Specify, and Vectris Spinal Cord Stimulatio
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S524
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-08-26
- Decision code
- OK30
- Date received
- 2022-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the surface finish inspection method.