Identity
- Trade Name
- VENASEAL CLOSURE SYSTEM FDA PMA
- Generic Name
- Agent, occluding, vascular, permanent FDA PMA
Identifiers
- PMA Number
- P140018 FDA PMA
- FDA Product Code
- PJQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Venaseal Closure System is a permanent vascular occluding agent designed for the treatment of lower extremity superficial truncal veins. It functions through endovascular embolization with coaptation to achieve closure of vessels such as the great saphenous vein.
This device is intended for use in adult patients who have been diagnosed with clinically symptomatic venous reflux via duplex ultrasound. The system is manufactured by Medtronic Vascular, Inc. and has received FDA PMA authorization for clinical use.
Frequently asked questions
What is the primary purpose of the Venaseal Closure System?
The Venaseal Closure System is used for the permanent closure of lower extremity superficial truncal veins, including the great saphenous vein, in patients suffering from symptomatic venous reflux.
Who is a candidate for treatment with this device?
The device is intended for use in adults who have been diagnosed with clinically symptomatic venous reflux, confirmed through a duplex ultrasound examination.
How does the Venaseal system achieve vein closure?
The system achieves closure through endovascular embolization with coaptation, which is a method of permanently occluding the target vascular structure.
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 | P140018 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular, Inc.
Sources (1)
- FDA PMA P140018 24 fields · synced Oct 6, 2026