Belotero Balance(R) Dermal Filler
FDA premarket approval P090016/S034 · decided 2022-09-07
Approval details
- PMA number
- P090016
- Supplement
- S034
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Belotero Balance(R) Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2019-08-22
- Decision date
- 2022-09-07
- Days to decision
- 1112 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Approval of an alternative contract manufacturer for secondary packaging operations and finished product warehousing and distribution of Belotero Balance.
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 |