- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S117
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2023-01-06
- Decision code
- APPR
- Date received
- 2022-08-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the order of the Quality Control Plan II testing within the calcium hydroxylapatite (CaHA) particle production process.