Restylane Defyne
FDA premarket approval P140029/S027 · decided 2021-01-29
Approval details
- PMA number
- P140029
- Supplement
- S027
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restylane Defyne
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-06-16
- Decision date
- 2021-01-29
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for Restylane Defyne. The device is indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion over the age of 21.
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