|
Device | JUVEDERM HYALURONATE GEL IMPKANTS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S019 |
Date Received | 08/01/2011 |
Decision Date | 09/23/2011 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM 12 MONTHS TO 24 MONTHS FOR THE 0.8ML SYRINGE (0.4ML AND 0.8ML VOLUMES); AN INCREASE IN THE MONOETHYLGLYCINEXYIDIDE (MEGX) IMPURITY SPECIFICATION FROM <= 0.3% W/W OF LABEL STRENGTH TO <= 2.0% W/W OF LABEL STRENGTH; AND AN INCREASE IN TOTAL IMPURITIES SPECIFICATION FROM <= 0.5% W/W OF LABEL STRENGTH TO <= 2.5% W/W OF LABEL STRENGTH. |