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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 NumberS007
Date Received12/11/2024
Decision Date05/13/2026
Product Code PRL 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for use of a new sterilization cycle with parametric release at the existing sterilizer
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