PMA P030050S044
- Device
- SCULPTRA®
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2023-12-07
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of compounding reactors and new transfer lines between the new reactors for increasing manufacturing capacity.
Current openFDA PMA Record
- Device
- SCULPTRA®
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S044
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-12-07
- Decision code
- OK30
- Date received
- 2023-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of compounding reactors and new transfer lines between the new reactors for increasing manufacturing capacity.