PMA P840001S518

Device: Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulat
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S518
Product code: LGW
Decision date: 2022-05-25
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Implement a validated thermal bonding rework process for the Spinal Cord Stimulation and Deep Brain Stimulation extensions manufactured at the Medtronic Villalba site.

Current openFDA PMA Record#

Device: Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulat
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S518
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-05-25
Decision code: OK30
Date received: 2022-05-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a validated thermal bonding rework process for the Spinal Cord Stimulation and Deep Brain Stimulation extensions manufactured at the Medtronic Villalba site.