- Device
- Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S623
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update to Model A71200 Vanta™ / Sequentia™ LT Clinician Programmer Application from version 2.0 to version 2.1 for spinal cord stimulation (SCS).