PMA P940015S007

Device: SYNVISC(HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S007
Product code: MOZ
Decision date: 2002-04-26
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "PRECAUTION: DO NOT OVER TIGHTEN OR APPLY EXCESSIVE LEVERAGE WHEN ATTACHING THE NEEDLE OR REMOVING THE NEEDLE GUARD, AS THIS MAY BREAK THE TIP OF THE SYRINGE."

Current openFDA PMA Record#

Device: SYNVISC(HYLAN G-F 20)
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S007
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2002-04-26
Decision code: APPR
Date received: 2002-03-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING STATEMENT TO THE SYNVISC PHYSICIAN PACKAGE INSERT: "PRECAUTION: DO NOT OVER TIGHTEN OR APPLY EXCESSIVE LEVERAGE WHEN ATTACHING THE NEEDLE OR REMOVING THE NEEDLE GUARD, AS THIS MAY BREAK THE TIP OF THE SYRINGE."