PMA P050052S143
- Device
- Radiesse® Injectable Implant, Radiesse® Hands
- Applicant
- Merz North America, Inc.
- Product code
- LMH
- Decision date
- 2024-01-25
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for a change to the in-process testing to determine moisture.
Current openFDA PMA Record
- Device
- Radiesse® Injectable Implant, Radiesse® Hands
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S143
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2024-01-25
- Decision code
- APPR
- Date received
- 2023-01-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the in-process testing to determine moisture.