Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
FDA premarket approval P090016/S038 · decided 2020-02-07
Approval details
- PMA number
- P090016
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2020-01-08
- Decision date
- 2020-02-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Changes to the NaHA assay for Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler, including the introduction of 125 mL HDPE bottles, the use of two series of 40 samples from each series, and the use of an alternate water source for testing.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |