2 results
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34ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
FDA Enforcement
Class III
·Terminated·Cardiocommand Inc.·June 19, 2019
TAPSYSTEM Model 2A, REF 8002A
FDA Enforcement
Class III
·Terminated·Cardiocommand Inc.·July 24, 2019