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. |
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Device | ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S009 |
Date Received | 05/22/2003 |
Decision Date | 07/02/2003 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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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