|
Device | JUVEDERM HYALURONATE GEL IMPLANTS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S051 |
Date Received | 09/28/2015 |
Decision Date | 10/23/2015 |
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 AN AUTOMATED VISUAL INSPECTION PROCESS AND ACCOMPANYING IN-PROCESS CONTROL FOR INSPECTING THE 0.8 ML SYRINGE CONFIGURATION OF JUVEDERM HYALURONATE GEL IMPLANTS. |