- Device
- Radiesse Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S111
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-06-08
- Decision code
- APPR
- Date received
- 2020-12-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the change in mixing the gel and media in a larger mixing bowl rather than multiple smaller mixing bowls during manufacturing of Radiesse Injectable Implant.