Restylane® Lyft with Lidocaine
FDA premarket approval P040024/S142 · decided 2025-11-04
Approval details
- PMA number
- P040024
- Supplement
- S142
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane® Lyft with Lidocaine
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2025-01-30
- Decision date
- 2025-11-04
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for Restylane® Lyft with Lidocaine for subcutaneous and/or supraperiosteal implantation for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild to moderate chin retrusion.
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