- Device
- Master Restore, Itrel , Synergy, Intellis , Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Specify,
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S624
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-05-07
- Decision code
- OK30
- Date received
- 2026-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement a new cleaning and passivation equipment at a Medtronic external supplier, Tegra Medical Dartmouth and Tegra Medical Costa Rica