PMA P050037S151
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S151
- Product code
- LMH
- Decision date
- 2026-03-24
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for implementation of a Green Sieve System used in the manufacture of CaHA particles used in the final RADIESSE and RADIESSE (+) devices
Current openFDA PMA Record#
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S151
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-03-24
- Decision code
- OK30
- Date received
- 2026-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a Green Sieve System used in the manufacture of CaHA particles used in the final RADIESSE and RADIESSE (+) devices