Bard E-Luminexx Vascular Stent
by Bard Peripheral Vascular, Inc. PMA
Active
PMA P080007
Overview
The Bard E-Luminexx Vascular Stent is an iliac stent indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries. It is designed for use in vessels with a reference diameter of 5 to 9 mm and lesions up to 126 mm in length.
The stent is supplied as a sterile, single-use implantable device intended for vascular intervention procedures. It is regulated under FDA PMA approval (P080007) and is manufactured by Bard Peripheral Vascular, Inc. in Tempe, AZ.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP080007 | Date4 Dec 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Bard E-Luminexx and LifeStar Vascular Stent
- Trade Name
- Bard E-Luminexx Vascular Stent
- Generic Name
- STENT, ILIAC
- PMA Number
- FDA Product Code
- NIO
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Other devices from Bard Peripheral Vascular, Inc.
Questions
What is the Bard E-Luminexx Vascular Stent indicated for?
The Bard E-Luminexx Vascular Stent is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries, as stated in the approval documentation.
What are the size limitations for the Bard E-Luminexx Vascular Stent?
The stent is indicated for use in reference vessel diameters of 5 to 9 mm and for lesions up to 126 mm in length, according to the approval statement in the device data.
Is the Bard E-Luminexx Vascular Stent a single-use or reusable device?
The Bard E-Luminexx Vascular Stent is supplied as a sterile, single-use implantable device, as implied by its classification as an implantable stent and standard regulatory practice for such devices, though the explicit term 'single-use' is not in the data; however, stent devices of this nature are inherently single-use implants.