Restylane® Lyft with Lidocaine
FDA premarket approval P040024/S146 · decided 2025-12-23
Approval details
- PMA number
- P040024
- Supplement
- S146
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Restylane® Lyft with Lidocaine
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2025-12-02
- Decision date
- 2025-12-23
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the postapproval study (PAS) protocol submitted to comply with the conditions of approval outlined in the approval order for P040024/S142.
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