BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE)
FDA premarket approval P090016/S006 · decided 2013-03-21
Approval details
- PMA number
- P090016
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2013-02-21
- Decision date
- 2013-03-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- MODIFICATION TO A PRODUCT RELEASE ASSESSMENT AND CRITERIA FOR FIN ISHED DEVICES.
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 |