PMA P940015S009

Device: SYNVISC (HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S009
Product code: MOZ
Decision date: 2003-03-14
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING PRECAUTION STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "TWIST THE GRAY TIP CAP BEFORE PULLING IT OFF, AS THIS WILL MINIMIZE PRODUCT LEAKAGE".

Current openFDA PMA Record#

Device: SYNVISC (HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S009
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2003-03-14
Decision code: APPR
Date received: 2003-02-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING PRECAUTION STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "TWIST THE GRAY TIP CAP BEFORE PULLING IT OFF, AS THIS WILL MINIMIZE PRODUCT LEAKAGE".