PMA P840001S521

Device: Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S521
Product code: LGW
Decision date: 2022-06-02
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Manufacturing process changes to transfer the XTC009 tantalum capacitor manufacturing process to a next generation medical-grade manufacturing process.

Current openFDA PMA Record#

Device: Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S521
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-06-02
Decision code: OK30
Date received: 2022-05-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing process changes to transfer the XTC009 tantalum capacitor manufacturing process to a next generation medical-grade manufacturing process.