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Synvisc Hylan G-F 20

by Sanofi Genzyme Corp.

PMA P940015

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P940015↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP940015 Date8 Aug 1997ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0607-2018 FDA Class II initiated 11 Dec 2017

    Contamination with Methylbacterium thiocyanatum

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Synvisc
Trade Name
Synvisc One
Generic Name
Acid, hyaluronic, intraarticular
PMA Number
FDA Product Code
MOZ
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Synvisc Hylan G-F 20 is an intraarticular hyaluronic acid derivative classified as an acid, hyaluronic, intraarticular device. It is designed to restore joint viscosity and lubrication in patients with osteoarthritis of the knee.

This device is supplied as a sterile, single-use injectable solution for intraarticular administration. It is indicated for pain relief in osteoarthritis of the knee when conservative therapies and simple analgesics have failed. Authorized under FDA PMA (P940015), it is intended for use in orthopedic settings and adheres to Class III regulatory standards.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Synvisc designed to address in patients with osteoarthritis of the knee, and how does it work?

    Synvisc is designed to restore joint viscosity and lubrication in patients with osteoarthritis of the knee. It works by providing a hyaluronic acid derivative that mimics the natural synovial fluid in the joint, helping to reduce pain and improve mobility when conservative treatments and simple analgesics have not been effective.

  • Is Synvisc intended for single-use or repeated use, and how is it administered?

    Synvisc is supplied as a sterile, single-use injectable solution. It is administered directly into the joint (intraarticular) by a healthcare professional in an orthopedic setting, typically as a series of injections to provide sustained relief.

  • What regulatory pathway was followed for Synvisc’s approval, and what does this mean for its use?

    Synvisc was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P940015. This pathway is used for high-risk medical devices like Synvisc, which is classified as a Class III device, ensuring rigorous evaluation of its safety and effectiveness for treating pain in osteoarthritis of the knee when other therapies fail.

  • Are there different sizes or models of Synvisc available, and how are they distinguished?

    Synvisc is available in multiple registration numbers (e.g., 3002864272, 3007093114, etc.), which correspond to different product codes (e.g., MOZ) and may reflect variations in packaging or batch sizes. However, the core formulation remains consistent as a hyaluronic acid derivative for intraarticular use, with no clinical differences implied by these identifiers.

  • How should Synvisc be stored, and what precautions should be taken before administration?

    Since Synvisc is a sterile, single-use injectable solution, it should be stored according to the manufacturer’s guidelines (typically refrigerated or at room temperature, as specified on the packaging). Before administration, verify sterility and expiration dates, and ensure the solution is clear and free of particulate matter to avoid contamination or adverse reactions during intraarticular injection.