PMA P030050S041
- Device
- Sculptra, Sculptra Aesthetic
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2024-04-18
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for deleting the tests for heavy metals at the release for raw material sodium carboxymethylcellulose (NaCMC).
Current openFDA PMA Record
- Device
- Sculptra, Sculptra Aesthetic
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S041
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-04-18
- Decision code
- APPR
- Date received
- 2023-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for deleting the tests for heavy metals at the release for raw material sodium carboxymethylcellulose (NaCMC).