PMA P250016
- Device
- Belotero® Intense (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250016
- Supplement
- S001
- Product code
- LMH
- Decision date
- 2026-08-05
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for modifications to the assay for determining the concentration of lidocaine hydrochloride and its impurities
Current openFDA PMA Record#
- Device
- Belotero® Intense (+) Lidocaine
- Applicant
- Merz North America, Inc.
- PMA number
- P250016
- Supplement
- S001
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-08-05
- Decision code
- OK30
- Date received
- 2026-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modifications to the assay for determining the concentration of lidocaine hydrochloride and its impurities