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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
valitude crt-p, valitude x4 crt-p, visionist crt-p, and visionist x4 crt-p

supplement #: S192
Guidant Corp. Dec 04, 2019 process change - manufacturer/sterilizer/packager/supplier  
crt-p resynchronization devices: invive, intua, visionist, valitude

supplement #: S193
Guidant Corp. Apr 01, 2020 change design/components/specifications/material  
pg valitude crt-p is1 el, is4 el, pg visionist crt-p is1 el, lv1 el, is4 el

supplement #: S194
Guidant Corp. Jan 28, 2020 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p, pg visionist crt-p, and intua crt-p

supplement #: S195
Guidant Corp. Mar 05, 2020 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p, valitude x4 crt-p, visionist crt-p, and visionist x4 crt-p

supplement #: S196
Guidant Corp. Mar 17, 2020 process change - manufacturer/sterilizer/packager/supplier  
(crt-p resynchronization devices) invive, intua, visionist, valitude

supplement #: S197
Guidant Corp. Jun 15, 2020 labeling change - indications/instructions/shelf life/tradename  
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S198
Guidant Corp. Aug 03, 2020 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4, visionist, visionist x4 - cardiac resynchronization therapy pacemaker (crt-p)

supplement #: S199
Guidant Corp. Sep 03, 2020 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist, valitude - crt-p resynchronization devices

supplement #: S200
Guidant Corp. Oct 22, 2020 change design/components/specifications/material  
valitude, valitude x4, visionist, and visionist x4 crt-p devices

supplement #: S201
Guidant Corp. Oct 16, 2020 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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