|
Device | Restylane® Kysse |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S021 |
Date Received | 09/03/2019 |
Decision Date | 03/26/2020 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
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 Kysse. The device is intended for injection into the lips for lip augmentation and for correction of upper perioral rhytids in patients over the age of 21. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |