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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 1X8 Synergy Extension; EZ Anchor; Injex BiWing Anchor; Injex Bumpy Anchor; Itrel 4 Neurostimulation System; Itrel 4 Neurostimulator; Itrel EZ Programmer; myStim Programmer; N'Vision Programmer; N'Vision Software Application Card; Pisces-Quad Compact Lead; Pisces-Quad Plus Lead; Prime Advanced Neurostimulation; PrimeAdvanced Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; RestoreAdvanced Neurostimulator; RestoreAdvanced SureScan MRI Neurostimulator; RestorePrime Neurostimulator; RestoreSensor Neurostimulator; RestoreSensor SureScan MRI Neurostimulator; RestoreUltra Neurostimulator; RestoreUltra SureScan MRI Neurostimulator; Resume II Lead; Resume TL Lead; Specify Lead; Stretch Coil Extension; Synergy EZ Programmer; Titan Anchor; Vectris SureScan Lead
Classification Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product Code: LGW
Device Class: 3
Registered Establishment Name: MEDTRONIC NEUROMODULATION
Registered Establishment Number: 2182207
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer; Specification Developer
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