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Multi-Link Vision Coronary Stent Systems

FDA PMA

Class III (US FDA PMA)

PMA P970020

by Abbott Vascular Inc.

Identity

Trade Name
MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS FDA PMA
Generic Name
STENT, CORONARY FDA PMA

Identifiers

PMA Number
P970020 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 Multi-Link Vision Coronary Stent Systems are coronary stents designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. These devices are intended for use in discrete de novo and restenotic native coronary artery lesions, with specific reference vessel diameters and lesion lengths as defined in the approved indications.

These stent systems are supplied as balloon-expandable devices with various delivery platforms, including ACS Multi-Link CSS, ACS RX Multi-Link HP CSS, and ACS OTW Multi-Link HP CSS. They are intended for single-use in clinical settings and have received FDA PMA approval (P970020). The systems are available in multiple sizes and configurations, as indicated by the associated FEI numbers, and are regulated under device class III (MAF product code).

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. Sources consulted: PDF Abbott Vascular MULIT-LINK VISION 2.75 CSS-U.S., PDF Abbott Vascular MULTI-LINK 8 SV, MULTI-LINK 8, and MULTI-LINK 8 LL ..., MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Vascular Inc.
FDA Applicant
Abbott Vascular, Inc.

Sources (1)

  • FDA PMA P970020 23 fields · synced Sep 18, 2026