PMA P040024S105
- Device
- RESTYLANE INJECTABLE GEL
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S105
- Product code
- LMH
- Decision date
- 2018-12-18
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Extension of shelf-life for HA raw material used in the manufacturing of Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, and Restylane Silk.
Current openFDA PMA Record#
- Device
- RESTYLANE INJECTABLE GEL
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S105
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2018-12-18
- Decision code
- OK30
- Date received
- 2018-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of shelf-life for HA raw material used in the manufacturing of Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, and Restylane Silk.