Multi-Link Vision and Multi-Link Mini-Vision Coronary Stent System

FDA PMA

Class III (US FDA PMA)

PMA P020047

by Abbott Vascular

Identity

Trade Name: MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS FDA PMA
Generic Name: STENT, CORONARY FDA PMA

Identifiers

PMA Number: P020047 FDA PMA
FDA Product Code: MAF FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA

The Multi-Link Vision and Multi-Link Mini-Vision Coronary Stent System is a coronary stent designed to improve coronary luminal diameter. It is indicated for patients with symptomatic ischemic heart disease involving discrete de novo or restenotic native coronary artery lesions, as well as lesions in saphenous vein bypass grafts. Additionally, the system is used to restore coronary flow in patients experiencing acute myocardial infarction within 12 hours of symptom onset.

This device is a permanent implant intended for use in lesions with reference vessel diameters ranging from 3.0 mm to 4.0 mm and lengths less than 25 mm. The system is available in both RX and OTW configurations. It has received FDA PMA approval for the specified clinical indications.

Frequently asked questions

What is the primary purpose of the Multi-Link Vision Stent System?

The system is designed to improve coronary luminal diameter in patients suffering from symptomatic ischemic heart disease or those experiencing an acute myocardial infarction.

Which types of lesions can be treated with this stent?

It is indicated for discrete de novo or restenotic native coronary artery lesions and lesions within saphenous vein bypass grafts that are less than 25 mm in length.

Is this device suitable for all vessel sizes?

No, the device is specifically indicated for use in vessels with reference diameters ranging from 3.0 mm to 4.0 mm.

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

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P020047	Class III	Active

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Manufacturer

Manufacturer: Abbott Vascular

Sources (1)

FDA PMA P020047 24 fields · synced Sep 18, 2026