PMA P030050S036
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S036
- Product code
- LMH
- Decision date
- 2021-04-28
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Moving the processes of filling, freeze drying, and capping into alternate cleanrooms.
Current openFDA PMA Record#
- Device
- Sculptra and Sculptra Aesthetic
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S036
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving the processes of filling, freeze drying, and capping into alternate cleanrooms.