PMA P940015S003

Device: SYNVISC (HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S003
Product code: MOZ
Decision date: 1999-12-20
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for a labeling change in the Physician Package Insert to reflect information in the Patient Package Insert regarding the time of maximum treatment effect.

Current openFDA PMA Record#

Device: SYNVISC (HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S003
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 1999-12-20
Decision code: APPR
Date received: 1999-04-07
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling change in the Physician Package Insert to reflect information in the Patient Package Insert regarding the time of maximum treatment effect.