Sculptra
FDA premarket approval P030050/S039 · decided 2023-04-25
Approval details
- PMA number
- P030050
- Supplement
- S039
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sculptra
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2022-02-09
- Decision date
- 2023-04-25
- Days to decision
- 440 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for Sculptra. The device is indicated for correction of fine lines and wrinkles in the cheek region for use in immune-competent subjects.
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