|
Device | Revanesse Versa+ with Lidocaine (1.0 mL and 1.2 mL) and Revanesse Lips+ with Lidocaine (1.0 mL and 1.2 mL) |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | PROLLENIUM MEDICAL TECHNOLOGIES INC. 138 INDUSTRIAL PARKWAY NORTH AURORA L4G 4 |
PMA Number | P160042 |
Supplement Number | S017 |
Date Received | 10/05/2021 |
Decision Date | 04/20/2022 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a change to the sample preparation in the Lidocaine HCl assay |