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Device | JUVEDERM VOLUMA XC |
Generic Name | implant, dermal, for aesthetic use |
Applicant |
Allergan |
2525 dupont dr. |
irvine, CA 92612 |
|
PMA Number | P110033 |
Date Received | 08/29/2011 |
Decision Date | 10/22/2013 |
Product Code |
LMH
|
Docket Number | 13M-1364 |
Notice Date | 11/20/2013 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials |
NCT00978042
|
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
APPROVAL FOR THE JUVEDERM VOLUMA TM XC. THIS DEVICE IS INDICATED FOR DEEP (SUBCUTANEOUS AND/OR SUPRAPERIOSTEAL) INJECTION FOR CHEEK AUGMENTATION TO CORRECT AGE-RELATED VOLUME DEFICIT IN THE MIDFACE IN ADULTS OVER THE AGE OF 21. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S029 S030 S025 S024 S027 S006 S005 S001 S010 S013 S009 S004 S008 S003 S016 S014 S023 S022 S026 S028 S021 S011 S019 S002 S018 S012 S007 S020 S015 S050 S041 S051 S045 S054 S056 S048 S036 S034 S035 S039 S037 S038 S057 S044 S043 S046 S052 S055 S040 S042 S047 S031 S033
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