PMA P250020S001
- Device
- Belotero Volume (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250020
- Supplement
- S001
- Product code
- LMH
- Decision date
- 2026-06-17
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for requalification of the cleanroom and controlled areas at the Merz Aesthetic GmbH production site
Current openFDA PMA Record#
- Device
- Belotero Volume (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250020
- Supplement
- S001
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-06-17
- Decision code
- OK30
- Date received
- 2026-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for requalification of the cleanroom and controlled areas at the Merz Aesthetic GmbH production site