PMA P840001S507

Device: Master Restore, ltrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spin
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S507
Product code: LGW
Decision date: 2022-01-19
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change in the ceramic material for multi-layer ceramic capacitors (MLCC) at Medtronics supplier. The components impacted are used within the hybrid electronic modules manufactured by Medtronics internal supplier.

Current openFDA PMA Record#

Device: Master Restore, ltrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spin
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S507
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the ceramic material for multi-layer ceramic capacitors (MLCC) at Medtronics supplier. The components impacted are used within the hybrid electronic modules manufactured by Medtronics internal supplier.