PMA P840001S503

Device: Master Restore, Itrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Yectris Spin
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S503
Product code: LGW
Decision date: 2021-12-03
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device: Master Restore, Itrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Yectris Spin
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S503
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-12-03
Decision code: OK30
Date received: 2021-11-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of current Underfill Dispense System (Asymtek Axiom X-1020) with a new system (Asymtek Spectrum II) at Medtronic Tempe Campus (MTC).