PMA P050037S118
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S118
- Product code
- LMH
- Decision date
- 2022-11-29
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom.
Current openFDA PMA Record#
- Device
- RADIESSE® Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P050037
- Supplement
- S118
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2022-11-29
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom.