Evolysse Injectable Hyaluronic Acid
FDA premarket approval P240022/S004 · decided 2025-12-19
Approval details
- PMA number
- P240022
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evolysse Injectable Hyaluronic Acid
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Symatese
- Date received
- 2025-12-05
- Decision date
- 2025-12-19
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Chaponost
- Statement
- Approval for a design change to the syringe plunger rod for the Evolysse injectable hyaluronic acid gels approved under P240022
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