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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.
 
DeviceMinima Stent System
Generic NameAortic stent
ApplicantRenata Medical, Inc.
4695 MacArthur Ct
Suite 440
Newport Beach, CA 92660
PMA NumberP240003
Date Received03/01/2024
Decision Date08/28/2024
Product Codes PNF QWC 
Advisory Committee Cardiovascular
Clinical TrialsNCT05086016
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5 kg in weight.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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