Minima Stent System
FDA premarket approval P240003 · decided 2024-08-28
Approval details
- PMA number
- P240003
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2024-03-01
- Decision date
- 2024-08-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- 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.
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