- Device
- Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™,
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S618
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-02-06
- Decision code
- OK30
- Date received
- 2026-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement process changes in the manufacture of the 90nm Integrated Circuit (IC) wafer components on behalf of an external supplier