Identity
- Trade Name
- EDWARDS INTUITY ELITE VALVE SYSTEM FDA PMA
- Generic Name
- heart-valve, non-allograft tissue FDA PMA
Identifiers
- PMA Number
- P150036 FDA PMA
- FDA Product Code
- LWR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Intuity Elite Valve System is a transcatheter heart valve designed for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Classified as a Class III device under FDA regulations, it is intended for percutaneous implantation via catheter-based techniques, offering a minimally invasive alternative to surgical aortic valve replacement.
This device is supplied sterile and intended for single-use. It is regulated under an FDA Premarket Approval (PMA) with PMA number P150036. The system is intended for use in cardiac catheterization laboratories and requires proper training and sterile handling. Compliance with manufacturer instructions and adherence to regulatory guidelines are essential for safe and effective deployment.
Frequently asked questions
What is the EDWARDS INTUITY ELITE Valve System used for in clinical practice?
The EDWARDS INTUITY ELITE Valve System is designed for replacing diseased, damaged, or malfunctioning native or prosthetic aortic valves. It is intended for percutaneous (catheter-based) implantation, providing a minimally invasive alternative to traditional surgical aortic valve replacement. This approach is typically used in cardiac catheterization labs for patients who may not be suitable for open-heart surgery.
How is the EDWARDS INTUITY ELITE Valve System supplied, and is it reusable?
The device is supplied sterile and is explicitly intended for **single-use only**. It comes pre-packaged for immediate clinical use, ensuring sterility and compliance with procedural requirements. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway does the EDWARDS INTUITY ELITE Valve System follow, and when was it approved?
The device is regulated under the FDA’s **Premarket Approval (PMA)** pathway, with PMA number **P150036**. It received approval on **August 12, 2016**, following a review by the FDA’s Cardiovascular (CV) advisory committee. This classification reflects its status as a **Class III** device, requiring rigorous pre-market evaluation.
Are there multiple sizes or models available for the EDWARDS INTUITY ELITE Valve System, and how are they identified?
Yes, the system includes multiple sizes/models, as indicated by the **OpenFDA registration numbers** (e.g., 3015287573, 3004478276). These correspond to different valve diameters or configurations to accommodate varying patient anatomies. The exact sizing details are outlined in the manufacturer’s instructions for use, which must be followed for proper selection and deployment.
Where and how should the EDWARDS INTUITY ELITE Valve System be stored before use?
The device should be stored in its **original sterile packaging** until ready for use, as it is supplied sterile. Storage conditions (e.g., temperature, humidity) are specified in the manufacturer’s instructions to maintain sterility and functionality. It is critical to handle the packaging carefully to avoid contamination before deployment in a cardiac catheterization lab.
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: Edwards Lifesciences – the leading global structural heart innovation ..., Produkte - Edwards Vacuum - Deutschland, Edwards Lifesciences – the leading global structural heart innovation ..., Edwards Lifesciences – Wikipedia, Edwards Lifesciences - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150036 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P150036 24 fields · synced Sep 18, 2026