FDA applicant

Advanced Bionics Corp.

Sylmar2 decisions1996–199717 recalls

FDA records 2 decisions for Advanced Bionics Corp. (Sylmar) from 1996 to 1997: 2 original PMA approvals. All are in product code MCM (Implant, Cochlear). 17 recalls are linked to its devices.

FDA’s records also spell it “Advanced Bionics”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Advanced Bionics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Bionics Corp. since 2007.

Recalls per year

2in 2026

2007high 5 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Advanced Bionics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Advanced Bionics Corp.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?