- Device
- Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S620
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-05-20
- Decision code
- APPR
- Date received
- 2026-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a revision to the stim engine integrated circuit (SEIC) for the impacted implantable neurostimulator models that increases robustness to low-energy cardioversion/defibrillation exposures