PMA P840001S534

Device: Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord Stim
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S534
Product code: LGW
Decision date: 2022-12-08
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Implementation of a validated test method for the incoming inspection of a component used at the Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device: Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord Stim
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S534
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-12-08
Decision code: OK30
Date received: 2022-11-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a validated test method for the incoming inspection of a component used at the Medtronic Energy and Component Center (MECC).