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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 FAMILY OF CRT-D
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS183
Date Received06/23/2008
Decision Date07/30/2009
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 programmer software application model 2845 version 4. 34 for the contak renewal (model h135), contak renewal 3 (models h170, h175), contak renewal 3 he (models h177, h179), contak renewal 3 rf (models h210, h215, h250, h255), and contak renewal 3 rf he (models h217, h219, h257, h259).
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