Bard E-Luminexx Vascular Stent

FDA premarket approval P080007 · Stent, Iliac

PMA numberP080007

Approval

Applicant
Bard Peripheral Vascular, Inc.
Received
March 21, 2008
Decision date
December 4, 2008 (APPR)
Supplements
24, latest May 26, 2022
Product code
NIO – Stent, Iliac

Official FDA PMA record

Approval order statement

APPROVAL FOR THE BARD E.LUMINEXX VASULAR STENT. THE DEVICE IS INDICATED FOR THE TREATMENT F ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.