|
Device | Juvéderm Injectable Gel Implants |
Generic Name | implant, dermal, for aesthetic use |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P050047 |
Supplement Number | S060 |
Date Received | 05/18/2017 |
Decision Date | 05/25/2017 |
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 | No |
Approval Order Statement Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations. |