PMA P840001S508

Device: Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spina Cord Stimulati
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S508
Product code: LGW
Decision date: 2022-02-04
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Addition of Integer as an alternate supplier for the Intellis Implantable Neurostimulator (INS) Titanium Shield Assembly component.

Current openFDA PMA Record#

Device: Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spina Cord Stimulati
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S508
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-02-04
Decision code: OK30
Date received: 2022-01-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of Integer as an alternate supplier for the Intellis Implantable Neurostimulator (INS) Titanium Shield Assembly component.