PMA P140029S042
- Device
- Restylane Refyne, Restylane Defyne, Restylane Kysse, Restylane Contour
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S042
- Product code
- LMH
- Decision date
- 2021-10-27
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Alternate sterility testing laboratory.
Current openFDA PMA Record#
- Device
- Restylane Refyne, Restylane Defyne, Restylane Kysse, Restylane Contour
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S042
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-10-27
- Decision code
- OK30
- Date received
- 2021-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate sterility testing laboratory.