PMA P050052S118
- Device
- Radiesse Injecable Implant, Radiesse (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S118
- Product code
- LMH
- Decision date
- 2019-12-26
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of an automated application of in process production labels.
Current openFDA PMA Record#
- Device
- Radiesse Injecable Implant, Radiesse (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S118
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-12-26
- Decision code
- OK30
- Date received
- 2019-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an automated application of in process production labels.