- Device
- RADIESSE Injectable Implant, including RADIESSE Hands, RADIESSE (+) Lidocaine, and RADIESSE (+) Jawline
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S134
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-02-02
- Decision code
- OK30
- Date received
- 2022-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Testing laboratory change for the incoming material testing and a testing method change for the metallic impurities.