Belotero Balance Dermal Filler
FDA premarket approval P090016/S035 · decided 2020-02-06
Approval details
- PMA number
- P090016
- Supplement
- S035
- Supplement type
- 135 Review Track For 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
- 2019-08-23
- Decision date
- 2020-02-06
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval for qualification of an alternative supplier of needles (27G x 1/2", 30G x 1/2") and modification of associated secondary packaging components to accommodate the new needles.
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 |