|
Device | Restylane Refyne, Restylane Defyne, and Restylane Kysse |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S034 |
Date Received | 10/07/2020 |
Decision Date | 11/06/2020 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane Refyne, Restylane Defyne, and Restylane Kysse. |