PMA P140029S016
- Device
- RESTYLANE Refyne and RESTYLANE Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S016
- Product code
- LMH
- Decision date
- 2019-03-15
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to the frequency for performing the In-Process Control of the syringe fill weights for Restylane Refyne and Restylane Defyne.
Current openFDA PMA Record#
- Device
- RESTYLANE Refyne and RESTYLANE Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S016
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-03-15
- Decision code
- OK30
- Date received
- 2019-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the frequency for performing the In-Process Control of the syringe fill weights for Restylane Refyne and Restylane Defyne.