Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RHA 2, RHA 3, RHA 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 | S018 |
Date Received | 07/16/2021 |
Decision Date | 08/13/2021 |
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 Addition of a new cleanroom and extension of maximum holding times at two points during the manufacturing of RHA 2, RHA 3, and RHA 4 gels. |
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