PMA P050052S124
- Device
- RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S124
- Product code
- LMH
- Decision date
- 2020-07-30
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Remove the Tumble Wash process step from the CaHA particle manufacturing process.
Current openFDA PMA Record#
- Device
- RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P050052
- Supplement
- S124
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-07-30
- Decision code
- OK30
- Date received
- 2020-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove the Tumble Wash process step from the CaHA particle manufacturing process.