|
Device | Juvederm Injectable Gel Implants |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S044 |
Date Received | 04/05/2019 |
Decision Date | 07/03/2019 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the implementation of the International Council for Harmonisation (ICH) elemental impurities guideline by the raw material supplier for the hyaluronic acid and lidocaine hydrochloride used in the manufacture of the Juvéderm Injectable Gel Implants. |