PMA P840001S530

Device: Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S530
Product code: LGW
Decision date: 2022-10-21
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Update the Olympus PC and Pain PC burn-in solution to use newly redesigned Burn In Boards and new burn-in software application at the Tempe Campus.

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: S530
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-10-21
Decision code: OK30
Date received: 2022-10-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update the Olympus PC and Pain PC burn-in solution to use newly redesigned Burn In Boards and new burn-in software application at the Tempe Campus.