|
Device | RHA 2, RHA 3, 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 | S017 |
Date Received | 04/26/2021 |
Decision Date | 05/26/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Changing the precision of the analytical testing performed during receiving inspection of the needles of RHA2, RHA3 and RHA4 dermal fillers. |