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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceALTO ICD MODELS 614 AND 615
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS006
Date Received11/28/2001
Decision Date12/21/2001
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ALTO ICD MODELS 614 AND 615. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALTO DR MODEL 614 ICD AND ALTO VR MODEL 615, AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA; 2) RECURRENT, POORLY TOLERATED, SUSTAINED VENTRICULAR TACHYCARDIA (VT). NOTE: THE CLINICAL OUTCOME FOR HEMODYNAMICALLY STABLE VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED.
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