- Device
- Sculptra
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S040
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-06-02
- Decision code
- APPR
- Date received
- 2022-12-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include 1) results from the 5-Year Post Approval Study; 2) device-specific use training program information; and 3) information on delayed-onset inflammation at the site of dermal filler injection following viral or bacterial illnesses or infections, vaccinations, or dental procedures.