- Device
- RADIESSE® Injectable Implant, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S135
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-05-05
- Decision code
- OK30
- Date received
- 2022-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the number of replicates used during the out of specification of endotoxin testing.