Belotero Balance (+) Lidocaine
FDA premarket approval P090016/S028 · decided 2019-08-29
Approval details
- PMA number
- P090016
- Supplement
- S028
- 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
- 2018-04-20
- Decision date
- 2019-08-29
- Days to decision
- 496 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for use of Belotero Balance with Integral Lidocaine for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |