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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONSULTA CRT-D & MAXIMO II CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS084
Date Received10/31/2007
Decision Date03/17/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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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