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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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239 supplements returned for P030005

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Device Name Company Date Approved Supplement Reason Other Information
contak renewal tr

supplement #: S034
Guidant Corp. May 12, 2006 process change - manufacturer/sterilizer/packager/supplier  
contak tr cardiac resynchronization therapy systems

supplement #: S035
Guidant Corp. Aug 25, 2006 labeling change - indications/instructions/shelf life/tradename  
contak renewal tr crt-p system

supplement #: S037
Guidant Corp. Jul 26, 2006 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S039
Guidant Corp. Feb 08, 2007 labeling change - indications/instructions/shelf life/tradename  
contak renewal tr family

supplement #: S040
Guidant Corp. Dec 06, 2006 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S041
Guidant Corp. Feb 16, 2007 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr family of pulse generators (pgs)

supplement #: S042
Guidant Corp. Mar 29, 2007 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr family of cardiac resynchronization therapy pacemakers

supplement #: S043
Guidant Corp. Apr 13, 2007 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S044
Guidant Corp. Aug 10, 2007 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr crt-p system

supplement #: S046
Guidant Corp. Dec 20, 2007 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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