- Device
- Belotero Volume (+) Lidocaine Dermal Filler
- Applicant
- Merz North America, Inc.
- PMA number
- P250020
- Supplement
- S005
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-09-10
- Decision code
- OK30
- Date received
- 2026-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for requalification of the cleanroom and controlled manufacturing areas at Merz Aesthetics GmbH facility (FEI 3036164410) affecting Belotero Volume (+) Lidocaine Dermal Filler