PMA P950027S010

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S010
Product code: MOZ
Decision date: 2008-01-08
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES IN THE LABEL: 1) THE ADDITION OF THE TRADE NAME, HYALECTIN, FOR SODIUM HYALURONATE IN THE DEVICE DESCRIPTION; AND 2) MODIFICATIONS TO THE CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS TO ENHANCE THE APPROPRIATE USAGE OF THE DEVICE.

Current openFDA PMA Record#

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S010
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2008-01-08
Decision code: APPR
Date received: 2007-12-07
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES IN THE LABEL: 1) THE ADDITION OF THE TRADE NAME, HYALECTIN, FOR SODIUM HYALURONATE IN THE DEVICE DESCRIPTION; AND 2) MODIFICATIONS TO THE CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS TO ENHANCE THE APPROPRIATE USAGE OF THE DEVICE.