|
Device | JUVEDERM HYALURONANTE GEL IMPLANTS |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S002 |
Date Received | 11/13/2007 |
Decision Date | 11/30/2007 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CLARIFICATIONS TO THE NEEDLE ATTACHMENT INSTRUCTIONS AND JUVEDERM 30 PHYSICIAN INSTRUCTIONS. |