PMA P950027S002

Device: HYALGAN(R)
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S002
Product code: MOZ
Decision date: 1999-12-18
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for modification of labeling to be modified and to add the information about the current clinical experience of the device as detailed in the amendment of 12/10/99.

Current openFDA PMA Record#

Device: HYALGAN(R)
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S002
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 1999-12-18
Decision code: APPR
Date received: 1998-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modification of labeling to be modified and to add the information about the current clinical experience of the device as detailed in the amendment of 12/10/99.