|
Device | BELOTERO BALANCE |
Generic Name | implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 courtney road suite 10 franksville, WI 53126 |
PMA Number | P090016 |
Date Received | 07/23/2009 |
Decision Date | 11/14/2011 |
Product Code |
LMH |
Docket Number | 11M-0832 |
Notice Date | 11/22/2011 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00876265
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR BELOTERO BALANCE. THIS DEVICE 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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S011 S010 S012 S014 S008 S016 S017 S015 S020 S022 S023 S025 S026 S027 S028 S030 S031 S032 S033 S035 S036 S037 S038 S042 S043 S044 S045 S046 S009 S018 S005 S006 S002 S013 S007 S004 S001 S019 S003 S048 |