PMA P050052S140
- Device
- RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S140
- Product code
- LMH
- Decision date
- 2022-11-30
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Addition of a modular ancillary cleanroom for device manufacturing.
Current openFDA PMA Record#
- Device
- RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S140
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-11-30
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a modular ancillary cleanroom for device manufacturing.