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LifeStream Balloon Expandable Vascular Covered Stent

by Bard Peripheral Vascular, Inc. PMA

Active United States

PMA P160024

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP160024 Date24 Apr 2017ApprovedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Recalls

1 recall · FDA

    • Terminated Z-0718-2020 FDA Class II initiated 18 Feb 2019

    Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.

Specification

PMA

Generic Name
Iliac covered stent, arterial
PMA Number
FDA Product Code
PRL
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LifeStream Balloon Expandable Vascular Covered Stent is an arterial iliac covered stent designed for the treatment of atherosclerotic lesions. It is indicated for use in common and external iliac arteries that have reference vessel diameters ranging from 4.5 mm to 12.0 mm and lesion lengths up to 100 mm.

This device is manufactured by Bard Peripheral Vascular, Inc. and has received FDA PMA authorization. It is designed for balloon-expandable deployment within the specified vascular anatomy to address arterial obstructions.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LifeStream Balloon Expandable Vascular Covered Stent used for?

    This device is indicated for the treatment of atherosclerotic lesions located in the common and external iliac arteries.

  • What are the vessel size requirements for this stent?

    The stent is indicated for use in vessels with reference diameters between 4.5 mm and 12.0 mm and for lesion lengths up to 100 mm.

  • Has this device been authorized by the FDA?

    Yes, the LifeStream Balloon Expandable Vascular Covered Stent has received FDA PMA authorization under number P160024.