ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER
FDA premarket approval P860008/S016 · decided 1998-08-28
Approval details
- PMA number
- P860008
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 1998-05-19
- Decision date
- 1998-08-28
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- 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
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