|
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 | S047 |
Date Received | 04/28/2015 |
Decision Date | 05/22/2015 |
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 CHANGING THE MANUAL VISUAL INSPECTION PROCESS TO AN AUTOMATED VISUAL INSPECTION PROCESS FOR THE 1.0 ML SYRINGES. |