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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.
 
DeviceSECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR
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 NumberS114
Date Received10/31/2007
Decision Date03/17/2008
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 REMOVAL OF THE CONTRAINDICATION: ?PATIENTS WHOSE PRIMARY DISORDER IS BRADYARRHYTHMIA? AND FOR THE MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284DRG, MAXIMO II VR D284VRC, MODEL 9995 APPLICATION SOFTWARE VERSION 1.1 SYSTEMS, MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME: MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK MEDTRONIC SECURA DR D224DRG, MEDTRONIC SECURA VR D224VRC, MAXIMO II DR D284VRC, MAXIMO II VR D284DRG MEDTRONIC 2490C CARELINK MONITOR, 2020A CARDIOSIGHT READER AND 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL MEDICAL THERAPY AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION. 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.
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