PMA P940015S004

Device

SYNVISC (HYLAN G-F 20)

Applicant

Sanofi Genzyme Corp.

PMA number

P940015

Supplement

S004

Product code

MOZ

Decision date

1999-05-26

Classification

Acid, Hyaluronic, Intraarticular

Generic name

Acid, hyaluronic, intraarticular

Approval order statement

Approval for labeling changes to the Physician Package Insert. The device, as modified, will be marketed under the trade name Synvisc(R) (Hylan G-F 20) and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen.

Summary

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