|
Device | Juvéderm Voluma XC, Juvéderm VollureTM XC, Juvéderm Volbella XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S030 |
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 | Yes |
Approval Order Statement Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations. |