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Euflexxa (1% Sodium Hyaluronate)

FDA PMA

Class III (US FDA PMA)

PMA P010029

by Ferring Pharmaceuticals, Inc.

Identity

Trade Name
EUFLEXXA (1% SODIUM HYALURONATE) FDA PMA
Generic Name
Acid, hyaluronic, intraarticular FDA PMA

Identifiers

PMA Number
P010029 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

Euflexxa is an intraarticular acid, hyaluronic, designed for the treatment of pain associated with osteoarthritis of the knee in patients who have not responded adequately to conservative non-pharmacologic therapy and simple analgesics. It is classified as a Class III medical device under FDA regulations.

The device is supplied as a sterile, single-use solution for intraarticular administration. Authorized under FDA PMA (P010029), it is intended for use in clinical settings where osteoarthritis management is required. Storage and handling must comply with sterile injection protocols, and its regulatory status is confirmed through the specified PMA approval.

Frequently asked questions

What is Euflexxa used to treat, and who is it intended for?

Euflexxa is an intraarticular hyaluronic acid solution approved for treating pain associated with osteoarthritis of the knee in patients who have not responded adequately to conservative non-pharmacologic therapies or simple analgesics like acetaminophen. It is specifically designed for clinical use in osteoarthritis management.

Is Euflexxa single-use or reusable, and how should it be stored?

Euflexxa is supplied as a sterile, single-use solution, meaning each vial is intended for one administration only. Storage and handling must follow sterile injection protocols to maintain its integrity and safety.

What regulatory approval does Euflexxa have, and how is it classified?

Euflexxa is classified as a Class III medical device under FDA regulations and is authorized through a Premarket Approval (PMA) with the PMA number **P010029**. This approval confirms its compliance with FDA standards for treating osteoarthritis-related knee pain.

Are there multiple sizes or models of Euflexxa available?

Euflexxa is supplied in multiple registration numbers (e.g., 3002864272, 3007093114, etc.), which may correspond to different lot or batch identifiers rather than distinct sizes or models. The product is consistently formulated as a 1% sodium hyaluronate solution for intraarticular use.

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: About EUFLEXXA – Euflexxa, Ferring Pharmaceuticals Inc. - Euflexxa, Euflexxa Solution Center

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Ferring Pharmaceuticals, Inc.

Sources (1)

  • FDA PMA P010029 24 fields · synced Sep 18, 2026