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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 NameCONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedevice resynchronization therapy-defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS031
Date Received08/18/2004
Decision Date02/09/2005
Product Code
LWP[ Registered Establishments with LWP ]
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 the addition of wandless telemetry to your currently market-approved crt-d devices that will allow communication with the programmer at an increased distance. The device, as modified, will be marketed under the trade name contak renewal 3 rf and is indicated for the following: the contak renewal 3 rf crt-d is indicated for patients with moderate to severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms.
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