PMA P840001S617

Device: External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis™ Model 97715; SCS Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S617
Product code: LGW
Decision date: 2026-02-12
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.

Current openFDA PMA Record#

Device: External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis™ Model 97715; SCS Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S617
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-02-12
Decision code: OK30
Date received: 2026-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.