Restylane Refyne and Restylane Defyne Injectable Gels
FDA premarket approval P140029/S022 · decided 2020-06-24
Approval details
- PMA number
- P140029
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restylane Refyne and Restylane Defyne Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2019-09-27
- Decision date
- 2020-06-24
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a new alternative supplier for Lidocaine Hydrochloride (Lidocaine HCl).
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