SCULPTRA (injectable poly-L Lactic acid) and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
FDA premarket approval P030050/S032 · decided 2021-05-18
Approval details
- PMA number
- P030050
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SCULPTRA (injectable poly-L Lactic acid) and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2020-03-23
- Decision date
- 2021-05-18
- Days to decision
- 421 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for updated labeling to reflect the incidence rate of adverse events through year three of the post approval study for SCULPTRA Aesthetic
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