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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: VAGUS NERVE STIMULATOR (VNS) SYSTEM
Classification Name: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Product Code: LYJ
Device Class: 3
Registered Establishment Name: LivaNova USA, Inc.
Registered Establishment Number: 1644487
Premarket Submission Number: P970003
Owner/Operator: LivaNova USA, Inc.
Owner/Operator Number: 9002738
Establishment Operations: Manufacturer; Complaint File Establishment
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