Sculptra and Sculptra Aesthetic
FDA premarket approval P030050/S042 · decided 2023-07-11
Approval details
- PMA number
- P030050
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sculptra and Sculptra Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2023-04-13
- Decision date
- 2023-07-11
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for revision of the bacterial endotoxin limits and test method for Sculptra finished product and raw materials.
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