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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceiCast Covered Stent System
Generic NameIliac covered stent, arterial
ApplicantAtrium Medical Corp.
5 Wentworth Dr.
Hudson, NH 03051
PMA NumberP120003
Supplement NumberS006
Date Received08/01/2024
Decision Date07/07/2025
Product Code PRL 
Advisory Committee Cardiovascular
Clinical TrialsNCT01208415
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a labeling update to reflect the use of the iCast Covered Stent System as a bridging stent between a branch vessel and an endovascular graft for treatment of patients with aneurysmal disease, limited to endovascular grafts that are approved for use with iCast
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