Symmetry™ VNS Therapy Kit Model 98142

Basic Information

• Brand Name: Symmetry™ VNS Therapy Kit Model 98142
• Primary DI: 05425025750511
• Version / Model: 98142
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 194568978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-23
• Public Version: 1
• Public Version Date: 2020-03-31
• Public Version Status: New
• Public Device Record Key: 6f9d3249-7917-4a03-9750-ecd9b7fbed06

Device Description

VNS Therapy Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
MUZ	Stimulator, Autonomic Nerve, Implanted (Depression)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35950	Vascular graft tunneller	A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.	No	Active
44041	Vagus nerve electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).	Yes	Active
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	05425025750511	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970003	225

Device Sizes

Type	Value	Unit	Text
Length	2	Millimeter

Storage Conditions

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