PMA P940015S033

Device: SYNVISC, SYNVISC-ONE
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S033
Product code: MOZ
Decision date: 2014-08-21
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS, ALLERGIC REACTIONS, AND HYPERSENSITIVITY.

Current openFDA PMA Record#

Device: SYNVISC, SYNVISC-ONE
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S033
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2014-08-21
Decision code: APPR
Date received: 2014-07-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE UPDATING OF THE PACKAGE INSERT AND PATIENT INFORMATION LEAFLET WITH RESPECT TO ADVERSE EVENT INFORMATION ON PSEUDOSEPSIS, ALLERGIC REACTIONS, AND HYPERSENSITIVITY.