Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: iCast Covered Stent System
• Generic Name: Iliac covered stent, arterial
• Applicant: Atrium Medical Corp.; 5 Wentworth Dr.; Hudson, NH 03051
• PMA Number: P120003
• Date Received: 03/08/2012
• Decision Date: 03/22/2023
• Product Code: PRL
• Docket Number: 23M-1104
• Notice Date: 04/11/2023
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00593385
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 S011