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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
invive, intua cardiac resynchronization therapy-pacemakers (crt-ps)

supplement #: S110
Guidant Corp. May 23, 2014 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p, contak renewal tr crt-p, intua crt-p

supplement #: S111
Guidant Corp. Jul 08, 2014 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr, invive and intua crt-p's

supplement #: S112
Guidant Corp. Jul 30, 2014 process change - manufacturer/sterilizer/packager/supplier  
ingenio 2 crt-p devices and ingenio crt-p devices

supplement #: S113
Guidant Corp. Oct 21, 2014 change design/components/specifications/material  
invive crt-ps, intua crt-ps

supplement #: S114
Guidant Corp. Nov 17, 2014 process change - manufacturer/sterilizer/packager/supplier  
invive, inliven, intua, valitude, valitude x4 (crt-p resynchronization devices

supplement #: S115
Guidant Corp. Jan 06, 2015 change design/components/specifications/material  
intua, invive, valitude, & valitude x4 crt-p's

supplement #: S116
Guidant Corp. Feb 25, 2015 change design/components/specifications/material  
invive and intua crt-ps

supplement #: S117
Guidant Corp. Mar 23, 2015 process change - manufacturer/sterilizer/packager/supplier  
invive, intua crt ps

supplement #: S118
Guidant Corp. Mar 27, 2015 process change - manufacturer/sterilizer/packager/supplier  
ingenio 2 crt-p devices

supplement #: S119
Guidant Corp. May 19, 2015 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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