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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.
 
DeviceALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Supplement NumberS009
Date Received05/22/2003
Decision Date07/02/2003
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 DOWN-SIZED VERSIONS OF THE ALTO MODELS DR 614 AND VR 615 IMPLANTABLE CARDIOVERTER DEFIBRILLATOS (ICDS), MODIFICATIONS TO THE ORCHESTRA APPLICATION SOFTWARE, AND THE ADDITION OF SEPARATELY PACKAGED IS-1 AND DF-1 PORT PLUGS. THE ICD DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ALTO DR MODEL 624 ICD AND ALTO VR MODEL 625, AND ARE 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. THE MODIFIED APPLICATION SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME ORCHESTRA APPLICATION SOFTWARE (ELAVIEW 1.06 UG2).
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