PMA P840001S608

Device: Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® S
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S608
Product code: LGW
Decision date: 2026-02-11
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: for a new solvent cleaner to be used in the Precision Machining & Manufacturing (PMM) processes

Current openFDA PMA Record#

Device: Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® S
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S608
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-02-11
Decision code: APPR
Date received: 2025-08-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a new solvent cleaner to be used in the Precision Machining & Manufacturing (PMM) processes