PMA P840001S495

Device: Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S495
Product code: LGW
Decision date: 2021-07-15
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.

Current openFDA PMA Record#

Device: Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S495
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-07-15
Decision code: OK30
Date received: 2021-07-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.