RHA® Redensity, RHA®2, RHA®3, RHA®4
FDA premarket approval P170002/S046 · decided 2024-10-23
Approval details
- PMA number
- P170002
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RHA® Redensity, RHA®2, RHA®3, RHA®4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2024-09-24
- Decision date
- 2024-10-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- Statement
- Reduce the number of samples tested for batch release for RHA® Redensity, RHA®2, RHA®3, RHA®4
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