- Device
- Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S036
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2020-02-04
- Decision code
- APPR
- Date received
- 2019-11-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to the package inserts and patient information guides for the Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler.