PMA P050037S153
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S153
- Product code
- LMH
- Decision date
- 2026-05-14
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®
Current openFDA PMA Record#
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S153
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-05-14
- Decision code
- OK30
- Date received
- 2026-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®