PMA P030050S049
- Device
- SCULPTRA®
- Applicant
- Q-Med AB
- Product code
- LMH
- Decision date
- 2024-03-07
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Implementation of automatic visual inspection equipment in the manufacture of the Sculptra products.
Current openFDA PMA Record
- Device
- SCULPTRA®
- Applicant
- Q-Med AB
- PMA number
- P030050
- Supplement
- S049
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-03-07
- Decision code
- OK30
- Date received
- 2024-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of automatic visual inspection equipment in the manufacture of the Sculptra products.