SCULPTRA (injectable poly-L Lactic acid)
FDA premarket approval P030050/S053 · decided 2024-11-13
Approval details
- PMA number
- P030050
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA (injectable poly-L Lactic acid)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2024-10-18
- Decision date
- 2024-11-13
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- to revamp Grade B, C and D clean rooms used for washing equipment/utensils and gowning in the manufacturing of Sculptra. The change also involves a minor impact to the filling room
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