Restylane Injectable Gel
FDA premarket approval P040024/S132 · decided 2022-12-20
Approval details
- PMA number
- P040024
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restylane Injectable Gel
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2022-09-06
- Decision date
- 2022-12-20
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the addition of lidocaine hydrochloride from a new manufacturing site of the lidocaine hydrochloride supplier.
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