PMA P950027S011

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S011
Product code: MOZ
Decision date: 2008-05-23
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR UPDATING THE SECTION OF ADVERSE EVENTS WITH A QUALITATIVE DESCRIPTION OF THE TYPES 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.

Current openFDA PMA Record#

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S011
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2008-05-23
Decision code: APPR
Date received: 2008-02-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATING THE SECTION OF ADVERSE EVENTS WITH A QUALITATIVE DESCRIPTION OF THE TYPES 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.