- Device
- Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, and V
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S609
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-02-13
- Decision code
- APPR
- Date received
- 2025-08-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of Spectra Medical as an alternate manufacturer for epidural needles included in Medtronic Spinal Cord Stimulation (SCS) lead and accessory kits.