- Device
- Restylane, Restylane Lyft with Lidocaine, Restylane Silk, Restylane-L, Perlane
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S123
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-11-16
- Decision code
- APPR
- Date received
- 2021-06-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add a new external sterility testing laboratory for end-product test before product release.