Nirflex Premounted Coronary Stent System
FDA PMAClass III (US FDA PMA)
by Medinol Ltd.
Identity
- Trade Name
- NIRFLEX PREMOUNTED STENT FDA PMA
- Generic Name
- STENT, CORONARY FDA PMA
Identifiers
- PMA Number
- P020040 FDA PMA
- FDA Product Code
- MAF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Nirflex Premounted Coronary Stent System is a coronary stent designed to improve coronary luminal diameter in patients. It is indicated for use in patients with symptomatic ischemic disease caused by discrete de novo and restenotic lesions in native coronary arteries.
This device is intended for lesions with a length of 25 mm or less and in vessels with a reference diameter ranging from 2.5 mm to 4.0 mm. The system is manufactured by Medinol Ltd. and has received FDA PMA authorization under number P020040.
Frequently asked questions
What is the Nirflex Premounted Coronary Stent System used for?
The device is indicated for improving the coronary luminal diameter in patients suffering from symptomatic ischemic disease caused by discrete de novo and restenotic lesions in native coronary arteries.
What are the vessel size requirements for this stent?
The stent is designed for use in native coronary arteries that have a reference vessel diameter between 2.5 mm and 4.0 mm, with lesion lengths of 25 mm or less.
Who manufactures the Nirflex Coronary Stent?
The Nirflex Premounted Coronary Stent System is manufactured by Medinol Ltd., based in Tel Aviv.
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 | P020040 | Class III | Active |
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Manufacturer
- Manufacturer
- Medinol Ltd.
- FDA Applicant
- Medinol, Ltd.
Sources (1)
- FDA PMA P020040 24 fields · synced Sep 18, 2026