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Stat-Pace II

FDA PMA

Class III (US FDA PMA)

PMA P840002

by Cardiocommand, Inc.

Identity

Trade Name
STAT-PACE II FDA PMA
Generic Name
SYSTEM, ESOPHAGEAL PACING FDA PMA

Identifiers

PMA Number
P840002 FDA PMA
FDA Product Code
LPA FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

Stat-Pace II is a system for esophageal pacing, classified under the generic name 'System, Esophageal Pacing'. It is designed to deliver electrical stimulation via an esophageal electrode to regulate heart rhythm.

The device was manufactured by Cardiocommand, Inc. in Tampa, Florida, and received FDA Premarket Approval (PMA) under number P840002 on April 30, 1986. It is intended for use in cardiovascular applications as indicated by its advisory committee classification.

Frequently asked questions

What type of device is the Stat-Pace II?

The Stat-Pace II is classified as a System, Esophageal Pacing, which delivers electrical stimulation through an esophageal electrode to manage cardiac rhythm.

Who manufactured the Stat-Pace II and where were they located?

The Stat-Pace II was manufactured by Cardiocommand, Inc., located at 4920 W. Cypress St., Suite 110, Tampa, FL 33607.

When did the Stat-Pace II receive regulatory approval?

The Stat-Pace II received FDA Premarket Approval (PMA) on April 30, 1986, with PMA number P840002 and decision date recorded as 1986-04-30.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Cardiocommand, Inc.

Sources (1)

  • FDA PMA P840002 24 fields · synced Sep 18, 2026