- Device
- Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S631
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-08-14
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.