PMA P840001S533

Device: Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S533
Product code: LGW
Decision date: 2022-11-22
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.

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: S533
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.