|
Device | Restylane Defyne |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S027 |
Date Received | 06/16/2020 |
Decision Date | 01/29/2021 |
Product Code |
LMH |
Docket Number | 21M-0153 |
Notice Date | 02/05/2021 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT03624816
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for Restylane Defyne. The device is indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion over the age of 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |