Synvisc, Synvisc-One
FDA premarket approval P940015/S052 · decided 2025-01-02
Approval details
- PMA number
- P940015
- Supplement
- S052
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Synvisc, Synvisc-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Sanofi Genzyme Corp.
- Date received
- 2024-12-03
- Decision date
- 2025-01-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cambridge, MA
- 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.
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