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Lifestent Flexstar and Flexstar XL Vascular Stent Systems

by Bard Peripheral Vascular, Inc.

PMA P070014

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P070014↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP070014 Date13 Feb 2009ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Lifestent Vascular Stent Systems
Trade Name
Lifestent Flexstar & Flexstar Xl Vascular Stent System
Generic Name
STENT, SUPERFICIAL FEMORAL ARTERY
PMA Number
FDA Product Code
NIP
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 Lifestent Flexstar and Flexstar XL Vascular Stent Systems are endovascular implants classified as stents for the superficial femoral artery (SFA) and proximal popliteal artery. These devices are designed to improve luminal diameter in symptomatic de-novo or restenotic lesions up to 160 mm in length within vessels ranging from 4.00 to 6.5 mm in diameter.

These stent systems are intended for use in interventional radiology and vascular surgery settings. Supplied as sterile, single-use devices, they are approved under an FDA Premarket Approval (PMA) and fall under device class III. The systems are not indicated for MRI use and must be handled and stored according to manufacturer instructions to maintain sterility and functionality.

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