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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
pg valitude crt-p, pg visionist crt-p

supplement #: S202
Guidant Corp. Oct 01, 2020 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p and pg visionist crt-p

supplement #: S203
Guidant Corp. Oct 22, 2020 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4, visionist and visionist x4

supplement #: S204
Guidant Corp. Nov 16, 2020 process change - manufacturer/sterilizer/packager/supplier  
contak renewal

supplement #: S205
Guidant Corp. Feb 02, 2021 change design/components/specifications/material  
valitude crt-p, valitude x4 crt-p, visionist crt-p, and visionist x4 crt-p

supplement #: S206
Guidant Corp. Dec 11, 2020 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr, valitude, invive, and intua

supplement #: S207
Guidant Corp. Apr 02, 2021 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p, valitude x4 crt-p, visionist crt-p, visionist x4 crt-p

supplement #: S208
Guidant Corp. Apr 30, 2021 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p, valitude x4 crt-p, visionist crt-p, visionist x4 crt-p

supplement #: S209
Guidant Corp. May 06, 2021 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4, visionist, visionist x4

supplement #: S210
Guidant Corp. Sep 03, 2021 change design/components/specifications/material  
invive, intua, visionist, valitude

supplement #: S211
Guidant Corp. Sep 17, 2021 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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