FDA applicant

Pacesetter Systems

Mchenry, IL98 decisions1976–19910 recalls

FDA records 98 decisions for Pacesetter Systems (Mchenry, IL) from 1976 to 1991: 96 510(k) clearances and 2 original PMA approvals. Most are in product codes DTB (Permanent Pacemaker Electrode) and DXY (Implantable Pacemaker Pulse-Generator). 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 Pacesetter Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacesetter Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Pacesetter”

FDA records each applicant name separately; these may or may not be the same firm.

Pacesetter, Inc. 8

Pacesetter Systems

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pacesetter”