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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 TR
Classification Namepermanent pacemaker electrode
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP030005
Supplement NumberS003
Date Received06/21/2004
Decision Date08/06/2004
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for programmer software application model 2865 version 1. 9.
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