Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler
FDA premarket approval P090016/S053 · decided 2023-05-18
Approval details
- PMA number
- P090016
- Supplement
- S053
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2023-04-28
- Decision date
- 2023-05-18
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for revisions to the instructions for use and patient information guides of Belotero Balance and Belotero Balance (+) Lidocaine Dermal Fillers as a result of postmarket surveillance data.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |