PMA P940015S010

Device

SYNVISC HYLAN G-F 20

Applicant

Sanofi Genzyme Corp.

PMA number

P940015

Supplement

S010

Product code

MOZ

Decision date

2003-09-12

Classification

Acid, Hyaluronic, Intraarticular

Generic name

Acid, hyaluronic, intraarticular

Approval order statement

APPROVAL FOR CHANGES TO THE PATIENT PACKAGE INSERT FOR SYNVISC THAT ARE INTENDED TO STRENGTHEN THE INFORMATION FOR PATIENTS BY INCREASING THE TYPE SIZE, DECREASING THE READING LEVEL, MORE FULLY DESCRIBING THE U.S. CLINICAL TRIAL, DESCRIBING THE SIGNS OF AN ALLERGIC REACTION, AND BY MAKING OTHER REVISIONS TO THE INSERT.

Summary

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