PMA P840001S615

Device: Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S615
Product code: LGW
Decision date: 2026-02-19
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for modifications to the Information for Prescribers (IFP) and Patient Therapy Guide (PTG) manuals to include “change in sexual function” as an adverse event and to move existing content, which states that safety and effectiveness of the subject device has not been established in pregnant and pediatric patients, to the warning section.

Current openFDA PMA Record#

Device: Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S615
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-02-19
Decision code: APPR
Date received: 2025-11-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the Information for Prescribers (IFP) and Patient Therapy Guide (PTG) manuals to include “change in sexual function” as an adverse event and to move existing content, which states that safety and effectiveness of the subject device has not been established in pregnant and pediatric patients, to the warning section.