- Device
- BELOTERO BALANCE Dermal Filler, BELOTERO BALANCE (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S037
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-10-02
- Decision code
- APPR
- Date received
- 2019-12-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a cloud-based environmental monitoring software system in designated production areas at Site 100 and Site 125.