PMA P140029S023
- Device
- Restylane Refyne and Restylane Defyne Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S023
- Product code
- LMH
- Decision date
- 2020-02-20
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change from single batch dialysis to dual-batch dialysis in manufacturing.
Current openFDA PMA Record#
- Device
- Restylane Refyne and Restylane Defyne Injectable Gels
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S023
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-02-20
- Decision code
- OK30
- Date received
- 2020-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change from single batch dialysis to dual-batch dialysis in manufacturing.