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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 1/3/3HE CRT-D DEVICES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedevice resynchronization therapy-defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS036
Date Received11/02/2004
Decision Date03/23/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the consult software model 2845 v2. 10 to be used to enable the ability to program the v-v timing interval in the contak renewal model h135; contak renewal 2 models h170 and 175; and contak renewal 3 he models h177 and h179 crt-d devices.
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