PMA P840001S629

Device: Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S629
Product code: LGW
Decision date: 2026-06-16
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.

Current openFDA PMA Record#

Device: Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S629
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-06-16
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.