Mozec™ PEB PTA

Primary DI

18904224912561

Basic UDI-DI Code

B-18904224912561

Reference

MO35P050060A

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

Mozec™ PEB PTA Paclitaxel Eluting PTA Balloon Catheter is designed for drug delivery while dilating stenotic or atherosclerotic lesions in peripheral arteries and post-delivery expansion of balloon expandable stents in the peripheral vasculature. Mozec™ PEB PTA Paclitaxel Eluting PTA Balloon Catheter (Mozec™ PEB PTA) consists of a drug (Paclitaxel) coated balloon (dilatation element) near the distal tip and dual lumen shaft. The balloon has two radiopaque marker bands one at each end of the balloon, which represent the approximate balloon working length at nominal pressure for correctly positioning the balloon under fluoroscopy. The proximal end has a Y luer hub for balloon inflation. The catheter has a soft tip at the distal end, dual lumen shaft which permit movement of guide wire and balloon inflation.The balloon coating consist of a blend of biocompatible formulation of antiproliferative drug (Paclitaxel) and excipients. The compliance chart on the inner and outer label indicates how the balloon diameter increases with increasing pressure. The compliance data is based on in vitro testing of balloons at 37°C temperature. -Guide wire compatibility: 0.035” - Paclitaxel Eluting PTA Balloon Catheter available with two usable length viz. 80 cm and 135 cm. The Mozec PEB PTA Paclitaxel Eluting PTA Balloon Catheter is available in different balloon sizes. Nominal balloon diameters and lengths are printed on the hub. Refer package label for information on catheter for Usable length, Nominal and Rated burst pressure and Sheath compatibility. Mozec™ PEB PTA is a transient use device (<60 minutes).

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).