PMA P030050S047
- Device
- Sculptra®
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2024-01-31
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of a new washing machine to the Sculptra manufacturing process in a new layout.
Current openFDA PMA Record
- Device
- Sculptra®
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S047
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-01-31
- Decision code
- OK30
- Date received
- 2024-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new washing machine to the Sculptra manufacturing process in a new layout.