|
Device | Revanesse Versa, Revanesse Versa + (with lidocaine), Revanesse Lips+ (with lidocaine) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 INDUSTRIAL PARKWAY NORTH AURORA L4G 4 |
PMA Number | P160042 |
Supplement Number | S013 |
Date Received | 11/02/2020 |
Decision Date | 02/08/2022 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a change in syringe for Revanesse Versa, Revanesse Versa+, and Revanesse Lips+. |