PMA P860008S016

Device: ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER
Applicant: Cardio Command
PMA number: P860008
Supplement: S016
Product code: LPA
Decision date: 1998-08-28
Classification: System, Esophageal Pacing
Generic name: SYSTEM, ESOPHAGEAL PACING
Approval order statement: The device is indicated for 1) the termination of supraventricular tachycardia (atrial flutter and re-entrant atrial or atrio-ventricular paroxysmal tachycardias) in children via an esophageal catheter electrode; 2) the acceleration of heart rate in adults via a Pill-Electrode as an alternative to exercise during diagnostic studies such as echocardiography or radionuclide ventriculography; and 3) use in patients who develop bradycardia during general anesthesia and require acceleration of heart rate.

Current openFDA PMA Record#

Device: ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER
Applicant: Cardio Command
PMA number: P860008
Supplement: S016
Product code: LPA
Generic name: SYSTEM, ESOPHAGEAL PACING
Decision date: 1998-08-28
Decision code: APPR
Date received: 1998-05-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The device is indicated for 1) the termination of supraventricular tachycardia (atrial flutter and re-entrant atrial or atrio-ventricular paroxysmal tachycardias) in children via an esophageal catheter electrode; 2) the acceleration of heart rate in adults via a Pill-Electrode as an alternative to exercise during diagnostic studies such as echocardiography or radionuclide ventriculography; and 3) use in patients who develop bradycardia during general anesthesia and require acceleration of heart rate.