Belotero Balance (+) Lidocaine Dermal Filler
FDA premarket approval P090016/S062 · decided 2024-12-10
Approval details
- PMA number
- P090016
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Belotero Balance (+) Lidocaine Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2024-09-13
- Decision date
- 2024-12-10
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for the qualification of the alternate secondary packaging design changes to the blister tray, blister lid and carton as well as to the syringe label and the shipping box in order to make them compatible with the new packaging line
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |