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Misago RX Self-Expanding Peripheral Stent

FDA PMA

Class III (US FDA PMA)

PMA P140002

by Terumo Medical Corporation

Identity

Trade Name
MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM FDA PMA
Generic Name
STENT, SUPERFICIAL FEMORAL ARTERY FDA PMA

Identifiers

PMA Number
P140002 FDA PMA
FDA Product Code
NIP FDA PMA

Classification

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

The Misago RX Self-Expanding Peripheral Stent is a stent, superficial femoral artery (per OpenFDA nomenclature), designed to improve luminal diameter in patients with de novo or restenotic native lesions or occlusions. It is intended for use in the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion lengths up to 150 mm.

This device is supplied as a self-expanding stent system and is approved for use in the United States under FDA_PMA (PMA Number: P140002). It is classified as a Class III medical device and is intended for single-use in interventional radiology or vascular surgery settings. No specific sterility or MRI safety information is provided in the data, but its use is restricted to the specified anatomical locations and lesion characteristics.

Frequently asked questions

What anatomical locations and types of lesions is the Misago RX Self-Expanding Peripheral Stent approved for use in?

The Misago RX Self-Expanding Peripheral Stent is approved for use in the superficial femoral artery (SFA) and/or proximal popliteal artery. It is specifically designed to improve luminal diameter in patients with de novo (new) or restenotic (recurrent narrowing) native lesions or occlusions. The device is intended for reference vessel diameters between 4 mm and 7 mm and lesion lengths up to 150 mm.

Is the Misago RX Self-Expanding Peripheral Stent system intended for reuse, or is it single-use only?

The Misago RX Self-Expanding Peripheral Stent system is explicitly intended for single-use in interventional radiology or vascular surgery settings. This is a standard practice for stents to ensure patient safety and sterility, as reuse could introduce risks of contamination or device degradation.

What regulatory pathway was followed for the approval of the Misago RX Self-Expanding Peripheral Stent in the United States?

The Misago RX Self-Expanding Peripheral Stent was approved in the United States through the FDA’s Premarket Approval (PMA) pathway, indicated by the PMA number P140002. This pathway is typically used for high-risk medical devices like Class III stents, ensuring rigorous evaluation of safety and effectiveness before market authorization.

Are there specific sizes or models available for the Misago RX Self-Expanding Peripheral Stent, and how does this relate to the vessel it’s intended for?

The Misago RX Self-Expanding Peripheral Stent is designed for reference vessel diameters ranging from 4 mm to 7 mm, accommodating the anatomical variations of the superficial femoral artery (SFA) and proximal popliteal artery. While the exact models or diameters aren’t listed in the data, the device’s specifications align with these vessel size constraints to ensure proper deployment and functionality.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Terumo Medical Corporation

Sources (1)

  • FDA PMA P140002 24 fields · synced Oct 6, 2026