Zilver Vena Venous Self-Expanding Stent
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Zilver Vena Venous Self-Expanding Stent FDA PMA
- Generic Name
- Stent, iliac vein FDA PMA
Identifiers
- PMA Number
- P200023 FDA PMA
- FDA Product Code
- QAN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Zilver Vena Venous Self-Expanding Stent is a self-expanding stent designed for placement in the iliofemoral veins. It is classified as a Stent, Iliac Vein and is intended to improve luminal diameter in patients with symptomatic iliofemoral venous outflow obstruction.
This device is supplied as a single-use, implantable medical product and is regulated under FDA Premarket Approval (PMA). It is intended for use in venous procedures and must be deployed under sterile conditions. The stent is available in various sizes as referenced by the registration numbers and is intended for use in the iliofemoral venous system.
Frequently asked questions
What is the Zilver Vena Venous Self-Expanding Stent primarily used for in clinical practice?
The Zilver Vena Venous Self-Expanding Stent is designed to improve the luminal diameter in patients with symptomatic iliofemoral venous outflow obstruction, specifically within the iliofemoral veins. It is intended to restore blood flow by maintaining an open vein passage, which helps alleviate symptoms related to venous blockages in this region.
How many sizes or models of the Zilver Vena Venous Self-Expanding Stent are available, and how are they identified?
The Zilver Vena Venous Self-Expanding Stent comes in multiple sizes, each identified by unique registration numbers such as 3002807314, 3009526575, 9681260, and others listed in the specifications. These numbers correspond to different stent dimensions to accommodate varying patient anatomies in the iliofemoral venous system.
Is the Zilver Vena Venous Self-Expanding Stent intended for single-use or reusable applications?
The Zilver Vena Venous Self-Expanding Stent is explicitly supplied as a single-use, implantable medical product. This means it is designed for one-time use within a patient and is not meant to be removed or reused after deployment.
What regulatory pathway was followed for the approval of the Zilver Vena Venous Self-Expanding Stent?
The Zilver Vena Venous Self-Expanding Stent was approved through the FDA’s Premarket Approval (PMA) process, which is the regulatory route for high-risk medical devices like stents. The approval was granted on October 9, 2020, following a review by the Cardiovascular (CV) advisory committee.
What precautions should be taken when handling the Zilver Vena Venous Self-Expanding Stent before deployment?
Since the Zilver Vena Venous Self-Expanding Stent is intended for sterile use, it must be deployed under aseptic conditions. The device should be handled carefully to avoid contamination, as it is a single-use implantable product designed for direct placement within the iliofemoral veins.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P200023 | Class III | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA PMA P200023 24 fields · synced Sep 18, 2026