- Device
- RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S136
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-09-02
- Decision code
- OK30
- Date received
- 2022-04-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a different blender into the Calcium Hydroxylapatite (CaHA) particle manufacturing process.