PMA P050052S117
- Device
- RADIESSE Injectable Implant and RADIESSE (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- Product code
- LMH
- Decision date
- 2020-03-02
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for the plunger design change for RADIESSE Injectable Implant and RADIESSE (+) Lidocaine Dermal Filler.
Current openFDA PMA Record#
- Device
- RADIESSE Injectable Implant and RADIESSE (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S117
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-03-02
- Decision code
- APPR
- Date received
- 2019-11-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the plunger design change for RADIESSE Injectable Implant and RADIESSE (+) Lidocaine Dermal Filler.