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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
cardiac resynchronization therapy- pacemaker (crt-p); invive & intua models; ingenio 2 crt-p devices valitude model u 12

supplement #: S141
Guidant Corp. Sep 13, 2016 process change - manufacturer/sterilizer/packager/supplier  
valitude; invive crt-ps

supplement #: S142
Guidant Corp. Sep 29, 2016 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, ingenio 2, valitude, valitude x4 crt-p

supplement #: S143
Guidant Corp. Oct 12, 2016 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p

supplement #: S144
Guidant Corp. Nov 03, 2016 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist, valitude crt-p's resynchronization devoces

supplement #: S145
Guidant Corp. Apr 17, 2017 change design/components/specifications/material  
valitude, valitude x4

supplement #: S146
Guidant Corp. Nov 30, 2016 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p models v172, v173; intua crt-p models v272, v273; valitude model u125; valitude x4 model u128;

supplement #: S147
Guidant Corp. Dec 12, 2016 process change - manufacturer/sterilizer/packager/supplier  
crt-p resynchronization devices, invive, intua, visionist, valitude

supplement #: S148
Guidant Corp. Feb 16, 2017 change design/components/specifications/material  
intua, invive, valitude, and visionist crt-ps

supplement #: S149
Guidant Corp. Jan 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
visionist cardiac resynchronization therapy pacemaker (crt-p) devices

supplement #: S150
Guidant Corp. Feb 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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