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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.
 
DeviceMEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS062
Date Received11/23/2005
Decision Date05/12/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE CONCERTO - VIRTUOSO V 1.0 SOFTWARE APPLICATION MODEL SW002. THE MEDTRONIC VIRTUOSO DR MODEL D154AWG DEVICE IS INDICATED AS FOLLOWS: THE DEVICE IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS IN PATIENTS WITH NYHA FUNCTIONAL CLASS II/III HEART FAILURE. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS.ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE PACING (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION. NOTES: 1) THE ICD FEATURES OF THE VIRTUOSO DEVICE FUNCTION THE SAME AS OTHER APPROVED MEDTRONIC MARKET-RELEASED ICDS. 2) DUE TO THE ADDITION OF THE OPTIVOL DIAGNOSTIC FEATURE, THE VIRTUOSO INDICATION IS LIMITED TO NYHA FUNCTIONAL CLASS II/III HEART FAILURE PATIENTS WHO ARE INDICATED FOR AN ICD. 3) THE CLINICAL VALUE OF THE OPTIVOL FLUID MONITORING DIAGNOSTIC FEATURE HAS NOT BEEN ASSESSED IN THOSE PATIENTS WHO DO NOT HAVE FLUID RETENTION RELATED SYMPTOMS DUE TO HEART FAILURE. 4) THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS. 5) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED. (CONT...)
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