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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 NameCONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantGUIDANT CORP.
PMA NumberP030005
Date Received03/24/2003
Decision Date01/26/2004
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 04M-0064
Notice Date 02/24/2004
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 contak renewal tr. The device is indicated s follows: the contak renewal tr pulse generator is indicated for patients who have moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy (as defined in the clinical trials section). The device provides atrial-ventricular tracking modes to help preserve av synchrony, and adaptive-rate pacing for patients who would benefit from adjusted pacing rates concurrent with physical activity.
Approval Order Approval Order
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