PMA P030050S056
- Device
- SCULPTRA® (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S056
- Product code
- LMH
- Decision date
- 2026-09-17
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval to modify compounding reactors R11 and R12 to be consistent with reactor systems R11A and R12A.
Current openFDA PMA Record#
- Device
- SCULPTRA® (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S056
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-09-17
- Decision code
- OK30
- Date received
- 2026-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to modify compounding reactors R11 and R12 to be consistent with reactor systems R11A and R12A.