Abre Venous Self-expanding Stent System | 合法醫療器材資訊網

2020年11月10日—PMAApplicant:MedtronicVascular,Inc.Address:3033CampusDrive,Plymouth,MN,55441.ApprovalDate:October21,2020.ApprovalLetter: ...

This is a brief overview of information related to FDAs approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDAs approval.

Product Name: Abre Venous Self-expanding Stent System PMA Applicant: Medtronic Vascular, Inc. Address: 3033 Campus Drive, Plymouth, MN, 55441 Approval Date: October 21, 2020 Approval Letter: Approval Order[1]

What is it? The Abre Venous Self-expanding Stent System has two components: a metal stent made from nickel titanium (nitinol) and a stent delivery system used to place the stent in a vein. The stent system is intended to treat deep venous obstruction, which occurs when a vein located in the groin area (iliofemoral vein) be...