- Device
- Sculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S031
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-02-28
- Decision code
- OK30
- Date received
- 2020-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the master protocol for requalification of the Cobalt-60 irradiation source used for gamma sterilization of PLLA and replacement of Cobalt-60 source and subsequent requalification performed in accordance with the revised protocol for Sculptra and Sculptra Aesthetic.