Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | JUVEDERM VOLUMA XC |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P110033 |
Supplement Number | S019 |
Date Received | 08/31/2015 |
Decision Date | 09/30/2015 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION. |
|
|