PMA P840001S481

Device: Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems, Pisces, Specify, and Vectris Spinal Cord Stimulati
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S481
Product code: LGW
Decision date: 2021-01-08
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Incorporate the Post Wafer Probe Check system to monitor the steps for all wafer lots that have completed wafer probe testing.

Current openFDA PMA Record#

Device: Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems, Pisces, Specify, and Vectris Spinal Cord Stimulati
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S481
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-01-08
Decision code: OK30
Date received: 2020-12-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Incorporate the Post Wafer Probe Check system to monitor the steps for all wafer lots that have completed wafer probe testing.