PMA P030050S033
- Device
- SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S033
- Product code
- LMH
- Decision date
- 2020-12-18
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of an alternate sterilization site for the flip-off seal used for Sculptra and Sculptra Aesthetic products.
Current openFDA PMA Record#
- Device
- SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid)
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S033
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-12-18
- Decision code
- OK30
- Date received
- 2020-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate sterilization site for the flip-off seal used for Sculptra and Sculptra Aesthetic products.