Sculptra and Sculptra Aesthetic
FDA premarket approval P030050/S036 · decided 2021-04-28
Approval details
- PMA number
- P030050
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sculptra and Sculptra Aesthetic
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2021-04-01
- Decision date
- 2021-04-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Moving the processes of filling, freeze drying, and capping into alternate cleanrooms.
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