|
Device | Restylane Contour |
Generic Name | implant, dermal, for aesthetic use |
Applicant | Q-Med AB seminariegatan 21 uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S043 |
Date Received | 11/05/2021 |
Decision Date | 11/30/2021 |
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 Introduce new equipment on one of the manufacturing lines that will enable a new alternative bulk process. |