iCast Covered Stent System

FDA premarket approval P120003 · Iliac covered stent, arterial

PMA numberP120003

Approval

Applicant
Atrium Medical Corp.
Received
March 8, 2012
Decision date
March 22, 2023 (APPR)
Supplements
11, latest May 13, 2026
Product code
PRL – Iliac Covered Stent, Arterial

Official FDA PMA record

Approval order statement

Approval of The iCAST Covered Stent System. The device is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the native common and/or external iliac arteries up to 110 mm in length, with a reference vessel diameter of 5 to 10 mm.