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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 models: u125, u128; visionist models: u225, u226, u228

supplement #: S151
Guidant Corp. Mar 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist, valitude

supplement #: S152
Guidant Corp. Sep 11, 2017 change design/components/specifications/material  
cardiac resynchronization therapy pacemaker models invive & intua

supplement #: S153
Guidant Corp. May 01, 2017 process change - manufacturer/sterilizer/packager/supplier  
valitude, visionist

supplement #: S154
Guidant Corp. May 01, 2017 process change - manufacturer/sterilizer/packager/supplier  
crt-p resynchronization devices invive, intua, visionist, valitude

supplement #: S155
Guidant Corp. Aug 07, 2017 change design/components/specifications/material  
torque wrench

supplement #: S156
Guidant Corp. Sep 11, 2017 change design/components/specifications/material  
valitude / valitude x4 / visionist / visionist x4

supplement #: S157
Guidant Corp. Sep 21, 2017 change design/components/specifications/material  
accolade cardiac resynchronization therapy pacemaker devices- valitude, valitude x4, visionist and visionist x4

supplement #: S158
Guidant Corp. Aug 30, 2017 process change - manufacturer/sterilizer/packager/supplier  
crt-p valitude, visionist

supplement #: S159
Guidant Corp. Aug 30, 2017 process change - manufacturer/sterilizer/packager/supplier  
crt-ps: invive, valitude, and visionist

supplement #: S160
Guidant Corp. Sep 25, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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