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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 #: S078
Guidant Corp. Jul 01, 2011 process change - manufacturer/sterilizer/packager/supplier  
invive v172, v173

supplement #: S079
Guidant Corp. May 01, 2012 change design/components/specifications/material Approval Order
renewal tr crt-p devices

supplement #: S080
Guidant Corp. Dec 05, 2011 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr

supplement #: S081
Guidant Corp. Feb 16, 2012 labeling change - indications/instructions/shelf life/tradename  
contak renewal tr cardiac resynchronization therapy pacemaker (crt-p) system family

supplement #: S082
Guidant Corp. Apr 23, 2012 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr crt-p devices

supplement #: S083
Guidant Corp. May 18, 2012 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p cardiac resynchronization therapy-pacemaker (crt-p)

supplement #: S084
Guidant Corp. Jun 25, 2012 process change - manufacturer/sterilizer/packager/supplier  
invive cardiac resynchronization therapy-pacemaker

supplement #: S085
Guidant Corp. Nov 14, 2012 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p and zoomview programmer

supplement #: S086
Guidant Corp. Aug 29, 2012 change design/components/specifications/material  
cardiac resynchronization therapy pacemaker (crt-p)

supplement #: S087
Guidant Corp. Oct 05, 2012 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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