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. |
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Device | Minima Stent System |
Generic Name | Aortic stent |
Applicant | Renata Medical, Inc. 4695 MacArthur Ct Suite 440 Newport Beach, CA 92660 |
PMA Number | P240003 |
Date Received | 03/01/2024 |
Decision Date | 08/28/2024 |
Product Codes |
PNF QWC |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05086016
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Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 |
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