PMA P030050
- Device
- SCULPTRA AND SCULPTRA AESTHETIC
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S038
- Product code
- LMH
- Decision date
- 2026-04-15
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval to terminate elemental impurity testing for Sculptra vial stoppers
Current openFDA PMA Record#
- Device
- SCULPTRA AND SCULPTRA AESTHETIC
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S054
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-04-15
- Decision code
- APPR
- Date received
- 2026-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to terminate elemental impurity testing for Sculptra vial stoppers