PMA P840001S621
- Device
- Master Intellis , Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S621
- Product code
- LGW
- Decision date
- 2026-04-03
- Classification
- Neurology
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
Current openFDA PMA Record#
- Device
- Master Intellis , Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (SCS Implantable Neurostimulators 97716, 97715, 9
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S621
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-04-03
- Decision code
- OK30
- Date received
- 2026-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier