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Hyalgan Acid, Hyaluronic, Intraarticular

FDA PMA

Class III (US FDA PMA)

PMA P950027

by Fidia Farmaceutici S.p.A.

Identity

Trade Name
HYALGAN(R) FDA PMA
Generic Name
Acid, hyaluronic, intraarticular FDA PMA

Identifiers

PMA Number
P950027 FDA PMA
FDA Product Code
MOZ FDA PMA

Classification

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

Hyalgan Acid, Hyaluronic, Intraarticular is an intra-articular hyaluronic acid injection classified as a Class III medical device. It is designed to provide lubrication and cushioning within the joint, aiding in the treatment of osteoarthritis-related pain and dysfunction by mimicking natural synovial fluid properties.

This sterile, single-use device is administered via intra-articular injection for the knee joint in patients unresponsive to conservative therapies. Supplied as a pre-filled syringe, it requires aseptic handling and refrigeration before use. Authorized under FDA PMA (P950027), it adheres to regulatory standards for intra-articular viscosupplementation and is distributed under the product code MOZ.

Frequently asked questions

What is Hyalgan® used for in clinical practice and who is it intended for?

Hyalgan® is an intra-articular hyaluronic acid injection designed to lubricate and cushion knee joints, helping manage pain and dysfunction in patients with osteoarthritis who haven’t responded well to non-pharmacologic therapies or simple pain relievers like acetaminophen. It’s specifically authorized for use in patients with knee osteoarthritis when conservative treatments have failed.

How is Hyalgan® supplied and what storage conditions are required?

Hyalgan® comes as a pre-filled syringe, ensuring sterility and ease of use. Since it’s a sterile, single-use device, it must be handled aseptically. The product requires refrigeration before administration to maintain its integrity and effectiveness.

Is Hyalgan® reusable or intended for single-use, and how does that affect its handling?

Hyalgan® is explicitly designed for single-use only. This means each pre-filled syringe is meant for one administration, reducing the risk of contamination and ensuring patient safety. Proper aseptic handling is critical to prevent cross-contamination, as reuse is not supported.

What regulatory pathway does Hyalgan® follow, and how does that impact its availability?

Hyalgan® is authorized under the FDA’s Premarket Approval (PMA) process, specifically with PMA number P950027. This pathway ensures it meets rigorous standards for safety and effectiveness as an intra-articular viscosupplement. Its approval status allows it to be distributed legally in the U.S. under the product code MOZ, adhering to FDA regulations for Class III devices.

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: HYALGAN - Fidia Farmaceutici, Official Website | Fidia Farmaceutici S.p.A, HYALGAN - Fidia Farmaceutici, Hyalgan, Hyaluronic Acid: Research and Projects | Fidia Farmaceutici

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Fidia Farmaceutici S.p.A.

Sources (1)

  • FDA PMA P950027 24 fields · synced Sep 18, 2026