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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Injex anchor; Itrel 2 Neurostimulation System; Itrel 3 Neurostimulation System; Itrel 4 Neurostimulation System; Itrel Spinal Cord Stimulation; N'Vision Programmer and Software Application Card; Prime Advanced Neurostimulation; PrimeAdvanced SureScan MRI Neurostimulator; Restore Advanced Neurostimulation; Restore Neurostimulation System; Restore Prime Neurostimulation; RestoreAdvanced SureScan MRI Rechareable Neurostimulator; RestoreSensor Neurostimulation System; RestoreUltra SureScan MRI Rechargeable Neurostimulator; SureScan; Synergy Compact Plus; Synergy Neurostimulation System; Synergy Plus; Synergy Versitrel Neurostimulation; Vectris; Vectris 1x8 Compact Trial Screening Lead; Vectris 1x8 SC Trial Screening Lead; Vectris SureScan MRI 1x8 Compact Lead; Vectris SureScan MRI 1x8 SC Lead Kit
Classification Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product Code: LGW
Device Class: 3
Registered Establishment Name: MEDTRONIC NEUROMODULATION
Registered Establishment Number: 3007566237
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer; Specification Developer
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