- Device
- Master Vanta™ with Restore™, Itrel™, Synergy™, Intellis™, AdaptiveStim™ Vanta™ and Inceptiv TM Spinal Cord Implantable S
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S632
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-10-06
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)