Sculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid)
FDA premarket approval P030050/S031 · decided 2020-02-28
Approval details
- PMA number
- P030050
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2020-01-31
- Decision date
- 2020-02-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change in the master protocol for requalification of the Cobalt-60 irradiation source used for gamma sterilization of PLLA and replacement of Cobalt-60 source and subsequent requalification performed in accordance with the revised protocol for Sculptra and Sculptra Aesthetic.
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