|
Device | JUVEDERM VOLUMA 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 | S025 |
Date Received | 12/23/2016 |
Decision Date | 01/17/2017 |
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 Change to the cleaning procedure of mixing and transfer vessels used during the manufacturing of Juvederm injectable gel products. |