PMA P040024S128
- Device
- Restylane® Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S128
- Product code
- LMH
- Decision date
- 2021-12-09
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane, Restylane-L, Restylane Lyft with Lidocaine, Perlane, and Restylane Silk.
Current openFDA PMA Record#
- Device
- Restylane® Injectable Gel
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S128
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane, Restylane-L, Restylane Lyft with Lidocaine, Perlane, and Restylane Silk.