PMA P840001S528

Device: Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S528
Product code: LGW
Decision date: 2022-09-13
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Replacement of inspection equipment at external supplier Innovize, Inc., for the inspection of components used at the Medtronic Energy and Component Center (MECC) site.

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: S528
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-09-13
Decision code: OK30
Date received: 2022-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of inspection equipment at external supplier Innovize, Inc., for the inspection of components used at the Medtronic Energy and Component Center (MECC) site.