Restylane-L; Restylane Lyft; Restylane Silk
FDA premarket approval P040024/S127 · decided 2022-10-25
Approval details
- PMA number
- P040024
- Supplement
- S127
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane-L; Restylane Lyft; Restylane Silk
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-09-29
- Decision date
- 2022-10-25
- Days to decision
- 391 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the transfer of the processing (washing and release) of plungers used in the manufacturing of Restylane-L®, Restylane Lyft® with Lidocaine, and Restylane® Silk to a new site.
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