VNS Therapy® AspireSR® Model 106 Generator

Basic Information

• Brand Name: VNS Therapy® AspireSR® Model 106 Generator
• Primary DI: 05425025750061
• Version / Model: 106
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 194568978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-02
• Public Version: 4
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: d5a7f0b0-15c7-45f1-892f-0e7e667c15fc

Device Description

Implantable Pulse Generator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
34210	Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system	An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05425025750061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970003	173

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius