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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Access Review Therapy Controller; Access Therapy Controller; Activa Parkinsons Control Therapy; Activa PC Neurostimulator; Activa RC Neurostimulator; Activa SC Neurostimulator; Activa Tremor Control Therapy; DBS Extension Kit; Intercept™; N'Vision Programmer; N'Vision Software Application Card; Percept™ PC BrainSense™; Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology; SenSight™; StimLoc
Classification Name: DEEP BRAIN STIMULATION FOR THE TREATMENT OF DYSTONIA
Product Code: SGS
Device Class: 3
Registered Establishment Name: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Registered Establishment Number: 3004209178
Premarket Submission Number: P960009
Owner/Operator: Medtronic, Inc.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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