Axonics Tined Lead (with Percutaneous Extension)

Primary DI

10810005340158

Basic UDI-DI Code

B-10810005340158

Reference

2201

Device Types

Single use Sterile Sterilization

Regulation

Eu Aimdd

Classification

Eu Aimdd Class

Status

On The Market

Manufacturer

Axonics Inc.

The Axonics Tined Lead has four (4) electrode contacts to provide stimulation. The distal tip is implanted through the applicable foramen near the S3 sacral nerve with the proximal end connected to the Neurostimulator. Tines on the lead facilitate fixation of the lead just posterior to the sacral foramen. This Model 2201 includes the Axonics Percutaneous Extension (Model 9009) that is a temporary and partially implanted device that is used to connect the implanted Axonics Tined Lead to the Axonics EPG (Model 1601) for the duration of the Trial SNM System. (Note, the Trial SNM System is used for a test period to evaluate if a patient should be treated with the Axonics SNM system)

Other on-the-market devices with the same classification (Eu Aimdd Class) and regulation (EU AIMDD).