SCULPTRA
FDA premarket approval P030050/S051 · decided 2024-10-09
Approval details
- PMA number
- P030050
- Supplement
- S051
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2024-05-17
- Decision date
- 2024-10-09
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- approval for an alternate sterilization manufacturing site
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