|
Device | Restylane Kysse Injectable Gel |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S029 |
Date Received | 08/17/2020 |
Decision Date | 12/21/2020 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a new alternative supplier for Lidocaine Hydrochloride (Lidocaine HCl) for Restylane Kysse |