|
Device | JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P050047 |
Supplement Number | S005 |
Date Received | 08/18/2008 |
Decision Date | 01/07/2010 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE ADDITION OF 0.3% LIDOCAINE INTO JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). |
Approval Order | Approval Order |