PMA P170002S014
- Device
- RHA 2, RHA 3, RHA 4 dermal fillers
- Applicant
- Teoxane S.A.
- PMA number
- P170002
- Supplement
- S014
- Product code
- LMH
- Decision date
- 2021-04-15
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for updated labeling to include adverse events from post market surveillance 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
- S014
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-15
- Decision code
- APPR
- Date received
- 2021-03-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling to include adverse events from post market surveillance for RHA 2, RHA 3, and RHA 4