FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Dermal, For Aesthetic Use
PMA: P040024
·
Supplement: S146
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Implant, Dermal, For Aesthetic Use
- Trade Name
- Restylane® Lyft with Lidocaine
- PMA Number
- P040024
- Supplement Number
- S146
- Device Class
- FDA Class 3
- Product Code
- LMH
- Generic Name
- Implant, dermal, for aesthetic use
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 23, 2025
- Date Received
- December 2, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for the postapproval study (PAS) protocol submitted to comply with the conditions of approval outlined in the approval order for P040024/S142.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | FDA class 3 | Unknown |