VNS Therapy® PerenniaDURA® Model 303 Lead

Basic Information

• Brand Name: VNS Therapy® PerenniaDURA® Model 303 Lead
• Primary DI: 05425025750122
• Version / Model: 303-30
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 194568978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: acc92135-9333-467b-b4d2-493bf5b8a19f

Device Description

Implantable Lead

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
MUZ	Stimulator, Autonomic Nerve, Implanted (Depression)	Unknown		3
LYJ	Stimulator, Autonomic Nerve, Implanted For Epilepsy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05425025750122	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970003	064
P970003	157

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.0	Millimeter

Storage Conditions

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