Mozec™ SEB

Primary DI

18904224904030

Basic UDI-DI Code

B-18904224904030

Reference

MOZS20020

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter is designed for delivering drug while dilating stenotic atherosclerotic lesions in coronary arteries and post-delivery expansion of balloon expandable stents. Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter (Mozec SEB) consists of a drug (Sirolimus) coated balloon (dilatation element) near the distal tip, a dual lumen distal shaft and single lumen proximal shaft. The balloon has two radiopaque marker bands, one at each end of the balloon, which represents the approximate balloon working length at nominal pressure for correctly positioning the balloon under fluoroscopy. The catheter has a soft tip. The two co-axial lumens permit movement of guide wire and balloon inflation. The two markers on the proximal shaft approximately indicate the exit of the balloon catheter tip from the guiding catheter (Brachial 90 cm, Femoral 100 cm). The proximal portion of the shaft has PTFE coating. The balloon coating consists of a blend of biocompatible Solid-Lipid Nano (SLN) formulation of anti-proliferative drug (Sirolimus) 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.

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