Sculptra and Sculptra Aesthetic
FDA premarket approval P030050/S043 · decided 2023-06-14
Approval details
- PMA number
- P030050
- Supplement
- S043
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sculptra and Sculptra Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2023-05-16
- Decision date
- 2023-06-14
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for revisions to the clinician labeling and patient labeling as a result of postmarket surveillance data.
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