RHA 2, RHA 3, RHA 4 dermal fillers
FDA premarket approval P170002/S004 · decided 2019-11-01
Approval details
- PMA number
- P170002
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA 2, RHA 3, RHA 4 dermal fillers
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2019-03-12
- Decision date
- 2019-11-01
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Approval for implementation of the International Council for Harmonization (ICH) elemental impurities guideline and change in the test method and specification to assay aluminum by the raw material supplier for the hyaluronic acid.
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