|
Device | JUVEDERM VOLUMA XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S005 |
Date Received | 03/20/2014 |
Decision Date | 04/14/2014 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00978042
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE ISO CLASSIFICATION OF THE SYRINGE DRYING, 100% VISUAL INSPECTION, SYRINGE ASSEMBLY AND THERMOFORMED TRAY PACKAGING ROOMS. |
Post-Approval Study | Show Report Schedule and Study Progress |