- Device
- RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi)
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S053
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-03-31
- Decision code
- APPR
- Date received
- 2026-01-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an increase of the manufacturing batch size for the RHA® Mepi family of products