PMA P050037S104
- Device
- RADIESSE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S104
- Product code
- LMH
- Decision date
- 2020-05-18
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Use of an alternative particle size analyzer.
Current openFDA PMA Record#
- Device
- RADIESSE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S104
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-05-18
- Decision code
- OK30
- Date received
- 2020-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an alternative particle size analyzer.