Belotero Balance Dermal Filler, Belotero Balance + Lidocaine Dermal Filler
FDA premarket approval P090016/S042 · decided 2020-12-22
Approval details
- PMA number
- P090016
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2020-06-23
- Decision date
- 2020-12-22
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for the addition of new release and shelf-life specifications for rheology and a change to the existing release and shelf-life specifications for ejection force for Belotero Balance Dermal Filler and Belotero Balance + Lidocaine Dermal Filler.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |