PMA P170002S025
- Device
- RHA® Redensity™, RHA ®2, RHA ®3, RHA ®4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S025
- Product code
- LMH
- Decision date
- 2023-01-26
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Manufacturing change to increase the mixing batch size from 12L to 24L.
Current openFDA PMA Record#
- Device
- RHA® Redensity™, RHA ®2, RHA ®3, RHA ®4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S025
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-01-26
- Decision code
- OK30
- Date received
- 2022-12-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to increase the mixing batch size from 12L to 24L.