Sculptra®
FDA premarket approval P030050/S045 · decided 2024-02-07
Approval details
- PMA number
- P030050
- Supplement
- S045
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sculptra®
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2023-12-28
- Decision date
- 2024-02-07
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- increase in poly l-lactic acid (PLLA) milling batch size for Sculptra
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.