|
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 | S046 |
Date Received | 05/28/2019 |
Decision Date | 06/26/2019 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for inclusion of an additional inspection step to the current manual inspection method during the manufacturing process for the Juvederm Injectable Gel Implants. |