PMA P840001S531

Device: Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S531
Product code: LGW
Decision date: 2022-11-16
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Implement a new external function used in finished device manufacturing that will automate pass or fail decisions on global monitors.

Current openFDA PMA Record#

Device: Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S531
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-11-16
Decision code: OK30
Date received: 2022-10-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a new external function used in finished device manufacturing that will automate pass or fail decisions on global monitors.