PMA P140029S015
- Device
- RESTYLANE REFYNE and RESTYLANE DEFYNE
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S015
- Product code
- LMH
- Decision date
- 2018-11-19
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change in the manufacturing procedure/introduction of an In-Process Control (IPC) used in the bulk process for Restylane Refyne and Restylane Defyne.
Current openFDA PMA Record#
- Device
- RESTYLANE REFYNE and RESTYLANE DEFYNE
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S015
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2018-11-19
- Decision code
- OK30
- Date received
- 2018-10-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing procedure/introduction of an In-Process Control (IPC) used in the bulk process for Restylane Refyne and Restylane Defyne.