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Device | ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER |
Generic Name | SYSTEM, ESOPHAGEAL PACING |
Applicant | CARDIO COMMAND 4920 WEST CYPRESS ST. STE.110 TAMPA, FL 33607 |
PMA Number | P860008 |
Supplement Number | S016 |
Date Received | 05/19/1998 |
Decision Date | 08/28/1998 |
Product Code |
LPA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |