- Device
- Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™,
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S619
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-02-27
- Decision code
- OK30
- Date received
- 2026-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a new Keyence Inspection System for the battery electrode compression process set-up