|
Device | RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | TEOXANE S.A. Les Charmilles Rue de Lyon 105 Geneva 1203 |
PMA Number | P170002 |
Supplement Number | S021 |
Date Received | 03/17/2022 |
Decision Date | 06/14/2022 |
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 design changes of the plunger and finger grip of the syringe. |