- Device
- Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S028
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-08-28
- Decision code
- OK30
- Date received
- 2020-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the sterilization validation approach to the overkill method/full cycle approach defined in ISO 17665-1:2006 Annex D4.