BELOTERO BALANCE
FDA premarket approval P090016 · decided 2011-11-14
Approval details
- PMA number
- P090016
- Trade name
- BELOTERO BALANCE
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2009-07-23
- Decision date
- 2011-11-14
- Days to decision
- 844 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR BELOTERO BALANCE. THIS DEVICE IS INDICATED FOR INJECTION INTO THE MID-TO-DEEP DERMIS FOR CORRECTION OF MODERATE-TO-SEVERE FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS.
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 |