PMA P040024S111
- Device
- Restylane Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S111
- Product code
- LMH
- Decision date
- 2019-06-19
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change in the sterilizer provider for the plungers used for Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine and Restylane Silk.
Current openFDA PMA Record#
- Device
- Restylane Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P040024
- Supplement
- S111
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-06-19
- Decision code
- OK30
- Date received
- 2019-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the sterilizer provider for the plungers used for Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine and Restylane Silk.