PMA P170002S051
- Device
- RHA® Redensity dermal filler
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S051
- Product code
- LMH
- Decision date
- 2026-01-14
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- correction of errors in the RHA® Redensity Instructions for Use (IFU)
Current openFDA PMA Record#
- Device
- RHA® Redensity dermal filler
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S051
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-01-14
- Decision code
- APPR
- Date received
- 2025-12-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- correction of errors in the RHA® Redensity Instructions for Use (IFU)