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Biotronik ASTRON Peripheral Self-Expanding Nitinol Stent System

FDA PMA

Class III (US FDA PMA)

PMA P140030

by Biotronik, Inc.

Identity

Trade Name
ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM FDA PMA
Generic Name
STENT, ILIAC FDA PMA

Identifiers

PMA Number
P140030 FDA PMA
FDA Product Code
NIO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The ASTRON Peripheral Self-Expanding Nitinol Stent System is a medical device indicated for improving luminal diameter in patients with iliac atherosclerotic lesions. The device is indicated for vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm.

The device is supplied as a sterile, single-use system. The stent is made of nitinol and is self-expanding. The device is regulated as a Class III medical device and has received FDA premarket approval (PMA).

Frequently asked questions

What is the ASTRON Peripheral Self-Expanding Nitinol Stent System used for?

The ASTRON Peripheral Self-Expanding Nitinol Stent System is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions. The device is indicated for vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm.

What are the specifications for the ASTRON Stent System?

The ASTRON Stent System is indicated for vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm. The device is a self-expanding nitinol stent system.

How is the ASTRON Stent System supplied and regulated?

The ASTRON Stent System is supplied as a sterile, single-use system. The device is regulated as a Class III medical device and has received FDA premarket approval (PMA).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Astron (Unternehmen) – Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Biotronik, Inc.
FDA Applicant
Biotronik AG

Sources (1)

  • FDA PMA P140030 24 fields · synced Sep 18, 2026