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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
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S242
Guidant Corp. Oct 23, 2024 process change - manufacturer/sterilizer/packager/supplier  
u125 valitude crt-p, u128 valitude x4 crt-p, u225 visionist crt-p, u226 visionist crt-p, u228 visionist x4 crt-p

supplement #: S243
Guidant Corp. Nov 25, 2024 process change - manufacturer/sterilizer/packager/supplier  
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S244
Guidant Corp. Dec 18, 2024 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p; valitude x4 crt-p; visionist crt-p; visionisnt x4 crt-p

supplement #: S245
Guidant Corp. Apr 11, 2025 process change - manufacturer/sterilizer/packager/supplier  
valitude™ (model u125); valitude™ x4 (model u128); visionist™ (models u225, u226); visionist™ x4 (model u228)

supplement #: S246
Guidant Corp. Jul 11, 2025 change design/components/specifications/material  
accolade crt – pacemakers (crt-ps): valitude crt-p u125; valitude x4 crt-p model u128; visionist crt-p models u225, u226

supplement #: S247
Guidant Corp. Jan 08, 2026 process change - manufacturer/sterilizer/packager/supplier  
accolade cardiac resynchronization therapy pacemakers, valitude (model u125); valitude x4 (model u128); visionist (model

supplement #: S248
Guidant Corp. Sep 22, 2025 process change - manufacturer/sterilizer/packager/supplier  
u125 valitude™ crt-p,u128 valitude™ x4 crt-p,u225 visionist™ crt-p,u226 visionist™ crt-p,u228 visionist™ x4 crt-p

supplement #: S249
Guidant Corp. Oct 22, 2025 process change - manufacturer/sterilizer/packager/supplier  
valitude™ (model u125) valitude™ x4 (model u128) visionist™ (models u225, u226) visionist™ x4 (model u228) firmware vers

supplement #: S250
Guidant Corp. Dec 19, 2025 change design/components/specifications/material  
valitude™ (model u125); valitude x4 (model u128); visionist™ (models u225, u226); visionist x4 (model u228)

supplement #: S251
Guidant Corp. Dec 17, 2025 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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