PMA P170002S015
- Device
- RHA 2, RHA 3, RHA 4 Dermal Fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S015
- Product code
- LMH
- Decision date
- 2021-04-26
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to the location of temperature sensors and biological indicators during the sterilization process qualification.
Current openFDA PMA Record#
- Device
- RHA 2, RHA 3, RHA 4 Dermal Fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S015
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-26
- Decision code
- OK30
- Date received
- 2021-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the location of temperature sensors and biological indicators during the sterilization process qualification.