PMA P030050S045
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- Sculptra®
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S045
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-02-07
- Decision code
- OK30
- Date received
- 2023-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- increase in poly l-lactic acid (PLLA) milling batch size for Sculptra