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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
6024 jean road
lake oswego, OR 97035
PMA NumberP050023
Date Received07/11/2005
Decision Date08/10/2006
Product Code
MRM[ Registered Establishments with MRM ]
Docket Number 06M-0367
Notice Date 09/08/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tupos lv/atx crt-d, kronos lv-t crt-d, 505. U programmer software for the ics 3000, a-k00. 7. U programmer software for the epr/tms 1000plus and corox otw steroid lead. The tupos lv/atx and kronos lv-t crt-ds are indicated for use in patients with all of the following conditions: 1) indicated for icd therapy; 2) receiving optimized and stable congestive heart failure (chf) drug therapy; 3) symptomatic chf (nyha class iii/iv and lvef <=35%); and 4) intraventricular conduction delay (qrs duration >=130 ms). The tupos lv/atx is also indicated for patients who, in addition to an indication for a crt-d device, have atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias. The corox otw steroid leads are intended for implantation via the coronary veins to provide long term cardiac pacing when used in conjunction with a compatible pulse generator.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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