|
Device | Juvederm Ultra XC and Ultra Plus XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S068 |
Date Received | 03/07/2019 |
Decision Date | 04/04/2019 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the addition of a specification for the lidocaine-related impurity, 2,6-dimethylaniline (DMA). |