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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, visionist™ x4 crt-p

supplement #: S232
Guidant Corp. Jul 21, 2023 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p is1 el us, pg valitude crt-p is4 el us, pg visionist crt-p is1 el us, pg visionist crt-p lv1 el us, pg

supplement #: S233
Guidant Corp. Oct 06, 2023 process change - manufacturer/sterilizer/packager/supplier  
valitude™ crt-p, valitude™ x4 crt-p, visionist™ crt-p, visionist™ x4 crt-p

supplement #: S234
Guidant Corp. Oct 18, 2023 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p, valitude x4 crt-p, visionist crt-p, visionist x4 crt-p

supplement #: S235
Guidant Corp. Dec 29, 2023 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist, valitude

supplement #: S236
Guidant Corp. Apr 30, 2024 change design/components/specifications/material  
valitude™, valitude x4, visionist™, visionist x4

supplement #: S237
Guidant Corp. Jun 04, 2024 change design/components/specifications/material  
latitude™ nxt patient management system (invive, intua, visionist, valitude)

supplement #: S238
Guidant Corp. Jul 18, 2024 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 #: S239
Guidant Corp. May 29, 2024 process change - manufacturer/sterilizer/packager/supplier  
cardiac resynchronization therapy pacemaker (crt-p)

supplement #: S240
Guidant Corp. Aug 28, 2024 labeling change - indications/instructions/shelf life/tradename  
accolade

supplement #: S241
Guidant Corp. Nov 01, 2024 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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