Sculptra
FDA premarket approval P030050/S040 · decided 2023-06-02
Approval details
- PMA number
- P030050
- Supplement
- S040
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Sculptra
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2022-12-06
- Decision date
- 2023-06-02
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- 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.
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