PMA P140029S040
- Device
- Restylane Refyne, Restylane Defyne, Restylane Kysse
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S040
- Product code
- LMH
- Decision date
- 2021-10-19
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for a new alternative bulk process on one manufacturing line to produce flexible batch sizes.
Current openFDA PMA Record#
- Device
- Restylane Refyne, Restylane Defyne, Restylane Kysse
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S040
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-10-19
- Decision code
- APPR
- Date received
- 2021-06-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new alternative bulk process on one manufacturing line to produce flexible batch sizes.