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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 NumberS009
Date Received06/16/2025
Decision Date12/22/2025
Product Code PRL 
Advisory Committee Cardiovascular
Clinical TrialsNCT00593385
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to add new implant sizes to the design matrix (10mm x 59mm stent, 32mm stent length, and 12mm stent diameter)
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