PMA P050052S132
- Device
- RADIESSE (+) Lidocaine Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S132
- Product code
- LMH
- Decision date
- 2021-10-21
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for inclusion of additional elemental impurities testing in accordance with USP <232>
Current openFDA PMA Record#
- Device
- RADIESSE (+) Lidocaine Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S132
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-10-21
- Decision code
- APPR
- Date received
- 2021-09-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for inclusion of additional elemental impurities testing in accordance with USP