PMA P950027S009

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S009
Product code: MOZ
Decision date: 2008-05-01
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE MANUFACTURING PROCESS FOR HYALGAN FOR PRODUCING HYALURONATE BY A BACTERIAL FERMENTATION 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: S009
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2008-05-01
Decision code: APPR
Date received: 2007-06-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE MANUFACTURING PROCESS FOR HYALGAN FOR PRODUCING HYALURONATE BY A BACTERIAL FERMENTATION 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.