|
Device | Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S035 |
Date Received | 01/21/2021 |
Decision Date | 06/11/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for installation of new equipment and modification of a control panel in clean rooms at Uppsala, Sweden |