FDA applicant

Cardiac Control Systems, Inc.

Palm Coast, FL28 decisions1983–19970 recalls

FDA records 28 decisions for Cardiac Control Systems, Inc. (Palm Coast, FL) from 1983 to 1997: 26 510(k) clearances and 2 original PMA approvals. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTB (Permanent Pacemaker Electrode). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiac Control Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiac Control Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiac Control Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cardiac Control Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?