PMA P030050S050
- Device
- SCULPTRA (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2024-04-29
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Change to add a second conveyor belt for irradiation of PLLA.
Current openFDA PMA Record
- Device
- SCULPTRA (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S050
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-04-29
- Decision code
- OK30
- Date received
- 2024-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to add a second conveyor belt for irradiation of PLLA.