PMA P040024S129
- Device
- Restylane-L, Restylane Lyft, Restylane Silk
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S129
- Product code
- LMH
- Decision date
- 2021-12-14
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of an alternate supplier of phosphoric acid solution for the manufacturing of Restylane-L®, Restylane Lyft® with Lidocaine and Restylane® Silk.
Current openFDA PMA Record#
- Device
- Restylane-L, Restylane Lyft, Restylane Silk
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S129
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-12-14
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of phosphoric acid solution for the manufacturing of Restylane-L®, Restylane Lyft® with Lidocaine and Restylane® Silk.