|
Device | Revanesse Versa, Revanesse Versa + |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 INDUSTRIAL PARKWAY NORTH AURORA L4G 4 |
PMA Number | P160042 |
Supplement Number | S004 |
Date Received | 05/29/2018 |
Decision Date | 03/15/2019 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the increase in syringe volume from 1.0 mL to 1.2 mL of Revanesse Versa and Revanesse Versa+. |