|
Device | Revanesse® Lips+ |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 INDUSTRIAL PARKWAY NORTH AURORA L4G 4 |
PMA Number | P160042 |
Supplement Number | S010 |
Date Received | 09/30/2019 |
Decision Date | 09/21/2020 |
Product Code |
LMH |
Docket Number | 20M-2021 |
Notice Date | 09/29/2020 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT04032977
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the Revanesse® Lips+. The device is indicated for submucosal implantation for lip augmentation in patients 22 years of age or older. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |