VNS Therapy® SenTiva™ Model 1000 Generator

GUDID 05425025750405

Implantable Pulse Generator

LIVANOVA USA, INC.

Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

• Primary Device ID: 05425025750405
• NIH Device Record Key: ab1cbe52-f322-4998-8d30-15d39f72106f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VNS Therapy® SenTiva™ Model 1000 Generator
• Version Model Number: 1000
• Company DUNS: 194568978
• Company Name: LIVANOVA USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (866) 882-8804
• Email: ClinicalTechnicalServices@livanova.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425025750405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970003

FDA Product Code

• LYJ: Stimulator, Autonomic Nerve, Implanted For Epilepsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-10-06

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