Belotero Balance Dermal Filler
FDA premarket approval P090016/S030 · decided 2018-07-25
Approval details
- PMA number
- P090016
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Belotero Balance Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2018-06-25
- Decision date
- 2018-07-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Change of analytical instrument used for determining the residual concentration of BDDE in Belotero Balance to ThermoScientific GC-MS/MS from Perkin-Elmer GC-MS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |