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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 PC Neurostimulator; Activa SC Neurostimulator; DBS Extension Kit; N'Vision Programmer; N'Vision Software Application Card; Percept™ PC BrainSense™; Reclaim Deep Brain Stimulation
Classification Name: STIMULATOR, BRAIN, IMPLANTED, FOR BEHAVIOR MODIFICATION
Product Code: MFR
Device Class: HDE
Registered Establishment Name: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Registered Establishment Number: 3004209178
Premarket Submission Number:
Owner/Operator: Medtronic, Inc.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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