|
Device | Juvederm injectable Gel |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S058 |
Date Received | 01/15/2021 |
Decision Date | 07/21/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the implementation of additional cleanrooms for the manufacturing of Juvéderm® Gel Implants and Juvéderm® Injectable Gel. |