Minima Stent System

FDA premarket approval P240003 · Aortic stent

PMA numberP240003

Approval

Applicant
Renata Medical, Inc.
Received
March 1, 2024
Decision date
August 28, 2024 (APPR)
Supplements
8, latest August 27, 2026
Product code
PNF – Aortic Stent

Official FDA PMA record

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.