PMA P030050S039
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- Sculptra
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S039
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-04-25
- Decision code
- APPR
- Date received
- 2022-02-09
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Sculptra. The device is indicated for correction of fine lines and wrinkles in the cheek region for use in immune-competent subjects.