|
Device | Juvederm Injectable Gel Implants |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S074 |
Date Received | 11/15/2019 |
Decision Date | 12/03/2019 |
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 additional cold room at the Pringy II manufacturing facility for the storage of raw materials for Juvéderm® injectable gel implants. |