PMA P090016S067
- Device
- Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S067
- Product code
- LMH
- Decision date
- 2026-05-03
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- approval for the use of sodium hyaluronate raw material manufactured at a new supplier production line
Current openFDA PMA Record#
- Device
- Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P090016
- Supplement
- S067
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-05-03
- Decision code
- APPR
- Date received
- 2025-08-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the use of sodium hyaluronate raw material manufactured at a new supplier production line