Identity
- Trade Name
- ZILVER VASCULAR STENT FDA PMA
- Generic Name
- STENT, ILIAC FDA PMA
Identifiers
- PMA Number
- P050017 FDA PMA
- FDA Product Code
- NIO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Zilver Vascular Stent is a Class III medical device classified as an iliac stent, designed to treat symptomatic vascular disease in the iliac arteries. It is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in patients with vessel diameters ranging from 5 to 9 mm and lesion lengths up to 100 mm, provided they are suitable for PTA and stent treatment.
This device is supplied sterile and intended for single-use. It is regulated under an FDA Premarket Approval (PMA) and is distributed in various sizes and configurations, as indicated by its registration numbers. The stent must be used in a clinical setting by trained medical professionals, adhering to standard sterile techniques and institutional protocols. No MRI safety information is specified in the available data.
Frequently asked questions
What is the Zilver Vascular Stent primarily used for in clinical practice?
The Zilver Vascular Stent is designed as an adjunct to percutaneous transluminal angioplasty (PTA) to treat symptomatic vascular disease in the iliac arteries. It is specifically intended for patients with iliac artery diameters between 5 and 9 mm and lesion lengths up to 100 mm, provided they are suitable candidates for PTA and stenting.
How many sizes or configurations are available for the Zilver Vascular Stent, and how are they identified?
The Zilver Vascular Stent is available in multiple sizes and configurations, as indicated by its registration numbers (e.g., 1058584, 3009526575, etc.). These registration numbers correspond to different stent dimensions and designs, allowing for flexibility in treating varying iliac artery anatomies within the specified 5–9 mm diameter and up to 100 mm lesion length range.
Is the Zilver Vascular Stent intended for reuse, or is it single-use only?
The Zilver Vascular Stent is explicitly supplied sterile and intended for single-use only. It must be used in a clinical setting by trained professionals, adhering to sterile techniques and institutional protocols, as reuse is not supported by its design or regulatory classification.
What regulatory pathway does the Zilver Vascular Stent follow, and what does this mean for clinicians?
The Zilver Vascular Stent follows the FDA Premarket Approval (PMA) pathway, indicated by its PMA number (P050017). This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use as an adjunct to PTA in iliac artery disease, providing clinicians with confidence in its regulatory validation.
Are there any special handling or storage requirements for the Zilver Vascular Stent?
While specific storage instructions are not detailed in the provided data, the stent is supplied sterile and intended for single-use in a clinical setting. As with all sterile medical devices, it should be stored according to manufacturer guidelines (likely in a sealed, protected environment) to maintain sterility until use. Always follow the accompanying packaging instructions or consult Cook Ireland’s official documentation for precise storage protocols.
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 | P050017 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA PMA P050017 24 fields · synced Sep 18, 2026