Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk
FDA premarket approval P040024/S093 · decided 2016-11-01
Approval details
- PMA number
- P040024
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2016-10-06
- Decision date
- 2016-11-01
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Addition of a sterilization site for plungers used with Restylane-L 2 mL and Perlane-L 2 mL.
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