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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceiCast Covered Stent System
Generic NameIliac covered stent, arterial
ApplicantATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051
PMA NumberP120003
Date Received03/08/2012
Decision Date03/22/2023
Product Code PRL 
Docket Number 23M-1104
Notice Date 04/11/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT00593385
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 
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