Belotero Balance (+) Lidocaine
FDA premarket approval P090016/S049 · decided 2022-10-26
Approval details
- PMA number
- P090016
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Belotero Balance (+) Lidocaine
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2022-07-21
- Decision date
- 2022-10-26
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval to increase the tolerance range for the lidocaine hydrochloride specification from 3.00 ± 5% mg/mL (2.85-3.15 mg/mL) to 3.0 ± 10% mg/mL (2.7 - 3.3 mg/mL).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |