Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels
FDA premarket approval P040024/S120 · decided 2020-10-14
Approval details
- PMA number
- P040024
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-09-14
- Decision date
- 2020-10-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Changes to the distribution systems for water for injection (WFI) and compressed air distribution systems at the Uppsala, Sweden manufacturing facility for Restylane, Perlane, Restylane L, Restylane Lyft with Lidocaine and Restylane Silk.
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