|
Device | Juvederm Voluma XC, Vollure XC, and Juvederm Volbella XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S038 |
Date Received | 04/02/2018 |
Decision Date | 05/01/2018 |
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 New ISO Class 8 cleanroom for use during the manufacturing of Juvéderm injectable gel products. |