PMA P840001S526

Device: Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S526
Product code: LGW
Decision date: 2022-09-07
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Repositing of equipment (and cleanroom) within the existing manufacturing facility of a critical supplier to Medtronic that manufactured fabricated metal components.

Current openFDA PMA Record#

Device: Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S526
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-09-07
Decision code: OK30
Date received: 2022-08-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Repositing of equipment (and cleanroom) within the existing manufacturing facility of a critical supplier to Medtronic that manufactured fabricated metal components.