PMA P140029S017
- Device
- Restylane Refyne, Restylane Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S017
- Product code
- LMH
- Decision date
- 2019-08-13
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for reclassification of impurity C in lidocaine HCl.
Current openFDA PMA Record#
- Device
- Restylane Refyne, Restylane Defyne
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S017
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-08-13
- Decision code
- APPR
- Date received
- 2019-05-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for reclassification of impurity C in lidocaine HCl.