PMA P940015S050

Device: Synvisc and Synvisc-One
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S050
Product code: MOZ
Decision date: 2022-11-04
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a warning statement regarding skin necrosis and the Synvisc® and Synvisc-One® patient labeling to include an advisory for the patient to inform his/her doctor in the event of development of a skin disorder after treatment.

Current openFDA PMA Record#

Device: Synvisc and Synvisc-One
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S050
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2022-11-04
Decision code: APPR
Date received: 2022-09-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a warning statement regarding skin necrosis and the Synvisc® and Synvisc-One® patient labeling to include an advisory for the patient to inform his/her doctor in the event of development of a skin disorder after treatment.