- Device
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S460
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-05-07
- Decision code
- OK30
- Date received
- 2020-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change requested to update the existing Soft Straight-Line Finish (SLF) cosmetic rework process at the Medtronic Puerto Rico Operations Company (MPROC), located in Juncos, Puerto Rico. The change also requested other related minor documentation updates