PMA P950027S001

Device: HYALGAN(R)
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S001
Product code: MOZ
Decision date: 1997-07-08
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE U.S. DISTRIBUTOR, SANOFI PHARMACEUTICALS, INC., NEW YORK, NEW YORK. ADDITIONALLY, WE HAVE REVIEWED THE EDITORIAL CHANGES YOU PROPOSE FOR THE LABELING FOR YOUR PRODUCT AND HAVE DETERMINED THAT THEY ARE APPROPRIATE.

Current openFDA PMA Record#

Device: HYALGAN(R)
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S001
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 1997-07-08
Decision code: APPR
Date received: 1997-06-24
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE U.S. DISTRIBUTOR, SANOFI PHARMACEUTICALS, INC., NEW YORK, NEW YORK. ADDITIONALLY, WE HAVE REVIEWED THE EDITORIAL CHANGES YOU PROPOSE FOR THE LABELING FOR YOUR PRODUCT AND HAVE DETERMINED THAT THEY ARE APPROPRIATE.