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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.
 
Trade NameTUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
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S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 
S058 S059 S060 S061 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S073 S075 
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