Astron Peripheral Self-Expanding Nitinol Stent System

FDA premarket approval P140030 · Stent, Iliac

PMA numberP140030

Approval

Applicant
Biotronik AG
Received
December 18, 2014
Decision date
December 17, 2015 (APPR)
Supplements
24, latest September 11, 2026
Product code
NIO – Stent, Iliac

Official FDA PMA record

Approval order statement

APPROVAL FOR THE ASTRON PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETERIN PATIENTS WITH ILIAC ATHEROSCLEROTIC LESIONS IN VESSEL REFERENCE DIAMETERS BETWEEN 4.3MM AND9.5MM AND LESION LENGTHS UP TO 105MM.