PMA P030050S042
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2023-07-11
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for revision of the bacterial endotoxin limits and test method for Sculptra finished product and raw materials.
Current openFDA PMA Record
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S042
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-07-11
- Decision code
- APPR
- Date received
- 2023-04-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for revision of the bacterial endotoxin limits and test method for Sculptra finished product and raw materials.