- Device
- Radiesse Injectable Implany and Radiesse (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S114
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-06-07
- Decision code
- OK30
- Date received
- 2019-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New moisture analyzer, Mettler Toledo model HE73, to replace a discontinued model moisture analyzer Mettler Toledo HR83.