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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

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
invive, intua, visionist, valitude

supplement #: S212
Guidant Corp. Nov 30, 2021 change design/components/specifications/material  
valitude crt-p, visionist crt-p

supplement #: S213
Guidant Corp. Sep 24, 2021 process change - manufacturer/sterilizer/packager/supplier  
valitude™ crt-p; valitude x4 crt-p

supplement #: S214
Guidant Corp. Oct 21, 2021 process change - manufacturer/sterilizer/packager/supplier  
crt-p resynchronization devices

supplement #: S215
Guidant Corp. Feb 24, 2022 change design/components/specifications/material  
u125 valitude™ crt-p, u128 valitude™ x4 crt-p, u225 visionist™ crt-p, u226 visionist™ crt-p, u228 visionist™ x4 crt-p

supplement #: S216
Guidant Corp. Dec 23, 2021 process change - manufacturer/sterilizer/packager/supplier  
valitude™ crt-p, valitude™ x4 crt-p, visionist™ crt-p, visionist™ x4 crt-p

supplement #: S217
Guidant Corp. Dec 21, 2021 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p, pg visionist crt-p

supplement #: S218
Guidant Corp. Jul 13, 2022 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p is1 el, pg valitude crt-p is4 el, pg visionist crt-p is1 el, pg visionist crt-p lv1 el, pg visionist c

supplement #: S219
Guidant Corp. Jul 27, 2022 process change - manufacturer/sterilizer/packager/supplier  
valitude™, valitude™ x4, visionist™, visionist™ x4

supplement #: S220
Guidant Corp. Nov 08, 2022 change design/components/specifications/material  
valitude™ crt-p, valitude x4 crt-p

supplement #: S221
Guidant Corp. Sep 27, 2022 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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