PMA P170002S009
- Device
- RHA 2, RHA 3, RHA 4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S009
- Product code
- LMH
- Decision date
- 2020-03-10
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of an alternative supplier of the reference standard lidocaine hydrochloride monohydrate used for the lidocaine assay for RHA 2, RHA 3, and RHA 4.
Current openFDA PMA Record#
- Device
- RHA 2, RHA 3, RHA 4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S009
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-03-10
- Decision code
- OK30
- Date received
- 2020-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative supplier of the reference standard lidocaine hydrochloride monohydrate used for the lidocaine assay for RHA 2, RHA 3, and RHA 4.