Data / Medical devices / Mexico / Advanced Bionics North American Operations Center S.A. de C.V.
Advanced Bionics North American Operations Center S.A. de C.V.: FDA-registered device maker in Mexicali Baja California, Mexico, 1 PMA approval
Advanced Bionics North American Operations Center S.A. de C.V. is registered with the FDA (registration 3030784382) in Mexicali Baja California, Mexico. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 26, 1997. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030784382
- Address
- Avenida Riba 875, Parque Industrial Condesa, Mexicali Baja California, Mexico, 21395
- Owner or operator
- Advanced Bionics LLC (10023794)
- Roles
- Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2027
- Brand names listed
- CLARION CII BIONIC EAR, HIRESOLUTION BIONIC EAR SYSTEM, Naida CI Q30, Naida CI Q70, Naida CI Q90, Naida CI M30 Sound Processor, Naida CI M90 Sound Processor, Sky CI M90 Sound Processor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Cochlear | MCM | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 26, 1997 | P960058 | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | MCM | 149 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.