Sculptra, Sculptra Aesthetic
FDA premarket approval P030050/S037 · decided 2022-06-27
Approval details
- PMA number
- P030050
- Supplement
- S037
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sculptra, Sculptra Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-11-10
- Decision date
- 2022-06-27
- Days to decision
- 229 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for replacement of an old autoclave with a new autoclave containing a new automated unloading system
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