Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: iCast Covered Stent System
• Generic Name: Iliac covered stent, arterial
• Applicant: Atrium Medical Corp.; 5 Wentworth Dr.; Hudson, NH 03051
• PMA Number: P120003
• Supplement Number: S003
• Date Received: 09/20/2023
• Decision Date: 10/18/2023
• Product Code: PRL
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
changes to the annealing of the Stainless Steel Tubing used to form the stent