Sculptra and Sculptra Aesthetic
FDA premarket approval P030050/S034 · decided 2021-11-23
Approval details
- PMA number
- P030050
- Supplement
- S034
- Supplement type
- Normal 180 Day 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
- 2020-11-27
- Decision date
- 2021-11-23
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for a change in reconstitution and injection procedure for Sculptra Aesthetic, combining the physician labeling for Sculptra and Sculptra Aesthetic, marketing Sculptra and Sculptra Aesthetic under the single trade name, Sculptra, and new secondary packaging
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