PMA P950027S006

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S006
Product code: MOZ
Decision date: 2005-07-19
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.

Current openFDA PMA Record#

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S006
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2005-07-19
Decision code: APPR
Date received: 2005-01-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFYING THE SPECIFICATIONS FOR THE ACTIVE INGREDIENT (SODIUM HYALURONATE) BY ELIMINATING THE ABNORMAL TOXICITY TEST AND REPLACING THE RABBIT PYROGEN TEST WITH THE BACTERIAL ENDOTOXINS TEST (LIMULUS AMOEBOCYTE LYSATE (LAL) TEST) AND MODIFYING THE SPECIFICATIONS FOR THE FINISHED PRODUCT TO REPLACE THE RABBIT PYROGEN TEST WITH THE LAL TEST.