PMA P940015

Device: Synvisc, Synvisc-One
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S051
Product code: MOZ
Decision date: 2025-01-02
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for revisions of the Synvisc® and Synvisc-One® physician labeling to include a precaution statement stating the device is only intended for use by healthcare professionals adequately trained to administer intra-articular injections and revisions to the Synvisc® and Synvisc-One® patient labeling to include the same advisory statement.

Current openFDA PMA Record#

Device: Synvisc, Synvisc-One
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S052
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-01-02
Decision code: APPR
Date received: 2024-12-03
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 precaution statement stating the device is only intended for use by healthcare professionals adequately trained to administer intra-articular injections and revisions to the Synvisc® and Synvisc-One® patient labeling to include the same advisory statement.