Sculptra and Sculptra Aesthetic
FDA premarket approval P030050/S035 · decided 2022-07-25
Approval details
- PMA number
- P030050
- Supplement
- S035
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sculptra and Sculptra Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-04-01
- Decision date
- 2022-07-25
- Days to decision
- 480 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval to implement new equipment for filling, lyophilization (freeze drying) and capping processes for Sculptra and Sculptra Aesthetic
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