|
Device | Juvederm Volbella XC |
Generic Name | implant, dermal, for aesthetic use |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P110033 |
Supplement Number | S035 |
Date Received | 11/20/2017 |
Decision Date | 12/14/2017 |
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 Implementation of an automated visual inspection process for Juvederm Volbella XC in the 0.55 mL fill volume configuration. |