PMA P170002S054
- Device
- RHA® Redensity, RHA® Redensity™ Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S054
- Product code
- LMH
- Decision date
- 2026-04-01
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for a change to bacterial endotoxin test management
Current openFDA PMA Record#
- Device
- RHA® Redensity, RHA® Redensity™ Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S054
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to bacterial endotoxin test management