|
Device | Juvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC |
Generic Name | implant, dermal, for aesthetic use |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P050047 |
Supplement Number | S058 |
Date Received | 03/20/2017 |
Decision Date | 08/25/2017 |
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 for an additional syringe assembly and packaging line. |