PMA P140029S020
- Device
- Restylane Refyne, Restylane Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S020
- Product code
- LMH
- Decision date
- 2019-09-13
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Remove window/wall sections and decommissioned packaging equipment and to install a new door in an ISO Class 8 clean room.
Current openFDA PMA Record#
- Device
- Restylane Refyne, Restylane Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S020
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-09-13
- Decision code
- OK30
- Date received
- 2019-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove window/wall sections and decommissioned packaging equipment and to install a new door in an ISO Class 8 clean room.