|
Device | JUVEDERM VOLUMA XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S008 |
Date Received | 05/13/2014 |
Decision Date | 06/10/2014 |
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 CHANGE TO THE UNIT OF MEASUREMENT FOR GEL TO BE MIXED AND A CHANGE TO THE IN PROCESS CONCENTRATION OF THE LIDOCAINE SOLUTION MIXED INTO THE GEL DURING HOMOGENIZATION. |