Device Dossier
SYNVISC-ONE (Hylan G-F 20) - Synovial fluid supplementation substance
Device Dossier for SYNVISC-ONE (Hylan G-F 20) - Synovial fluid supplementation substance (Synovial fluid supplementation substance, Class III, sponsor…
- GMDN category: Synovial fluid supplementation substance
- Sponsor: Sanofi-Aventis
Intended purpose
Synvisc-One is only intended for intra-articular use to treat pain associated with osteoarthritis of the knee.
Functional description
A sterile, nonpyrogenic, elastoviscous fluid containing hylan polycaccharide (Hylan polymer 8.0 mg/mL) hydrated in physiological saline.