Identity
- Trade Name
- Minima Stent System FDA PMA
- Generic Name
- Aortic stent FDA PMA
Identifiers
- PMA Number
- P240003 FDA PMA
- FDA Product Code
- PNF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Minima Stent System is an expandable metal mesh tube classified as an Aortic Stent (Device Class III) under FDA regulations. It is designed to treat native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children weighing at least 1.5 kg. The device is intended for percutaneous placement within the vascular system to restore lumen diameter and improve blood flow in narrowed segments.
The Minima Stent System is supplied as a single-use, sterile device and is regulated under FDA PMA (P240003). Deployment requires fluoroscopic guidance and is performed in a catheterization laboratory setting. Compatibility with MRI safety is not specified in the data. The system is available in sizes and configurations referenced in the PMA submission, with storage and handling per manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What patient population is the Minima Stent System designed to treat, and what conditions does it address?
The Minima Stent System is specifically designed for **neonates, infants, and children weighing at least 1.5 kg** to treat **native or acquired pulmonary artery stenoses** (narrowing of the pulmonary artery) or **coarctation of the aorta** (a congenital narrowing of the aorta). It is intended to restore blood flow by expanding the narrowed segment of the vessel, improving lumen diameter and circulation.
Is the Minima Stent System reusable, or is it meant for single-use only?
The Minima Stent System is **supplied as a single-use, sterile device**, meaning it is intended for one-time use per patient. Reuse is not recommended or supported by the manufacturer to ensure safety and efficacy.
What types of sizes or configurations are available for the Minima Stent System, and how are they determined?
The Minima Stent System comes in **various sizes and configurations**, as referenced in the FDA PMA submission (P240003). The specific dimensions are tailored to accommodate different patient anatomies, particularly the vascular diameters of neonates, infants, and children. The manufacturer’s instructions should be consulted for exact sizing details, as these are critical for proper deployment and effectiveness.
How should the Minima Stent System be stored to maintain its sterility and functionality?
The Minima Stent System must be stored and handled **strictly according to the manufacturer’s instructions** to preserve sterility and ensure proper functionality. This includes keeping it in its original packaging, away from contamination, and adhering to any temperature or environmental guidelines provided by Renata Medical, Inc.
Where and how is the Minima Stent System deployed, and what guidance is required?
The Minima Stent System is **percutaneously placed within the vascular system** under **fluoroscopic guidance** in a **catheterization laboratory** setting. This procedure requires specialized medical equipment and expertise to ensure accurate deployment and optimal outcomes for the patient.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Renata Medical - Minima Pro™, Renata Medical, RENATA FG-0001 Minima Stent System Instruction Manual, Minima Stent System - P240003 | FDA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P240003 | Class III | Active |
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Manufacturer
- Manufacturer
- Renata Medical, Inc.
Sources (1)
- FDA PMA P240003 23 fields · synced Sep 18, 2026