|
Device | REVANESSE ULTRA |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 INDUSTRIAL PARKWAY NORTH AURORA L4G 4 |
PMA Number | P160042 |
Date Received | 09/22/2016 |
Decision Date | 08/04/2017 |
Product Code |
LMH |
Docket Number | 17M-4711 |
Notice Date | 08/07/2017 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT02984878
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Revanesse Ultra. The 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, in adults 22 years of age or more. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S009 S015 S019 S017 S022 S001 S004 S003 S007 S010 S011 S012 S020 S013 S014 S018 S023 |