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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
ingenio crt-p devices (invive, intua), ingenio 2 crt-p devices (valitude, valitude x4, visiionist, visionist x4)

supplement #: S171
Guidant Corp. Feb 02, 2018 change design/components/specifications/material  
invive, intua, visionist, valitude

supplement #: S172
Guidant Corp. Mar 26, 2018 labeling change - indications/instructions/shelf life/tradename  
valitude crt-p; valitude x4 crt-p; visionist

supplement #: S173
Guidant Corp. Feb 08, 2018 process change - manufacturer/sterilizer/packager/supplier  
accolade cardiac resynchronization therapy-pacemaker (crt-p) devices: invive tm, intua tm, valitude, valitude x4, vision

supplement #: S174
Guidant Corp. Mar 12, 2018 process change - manufacturer/sterilizer/packager/supplier  
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S175
Guidant Corp. Apr 25, 2018 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p, intua crt-p, valitude crt-p, visionist crt-p, valitude x4 crt-p, visionist x4 crt-p, and programmer softwa

supplement #: S176
Guidant Corp. Jul 27, 2018 change design/components/specifications/material  
invive, intua, valitude, valitude x4, visionist, visionist x4

supplement #: S178
Guidant Corp. Nov 16, 2018 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist and valitude (crt-p resynchronization devices)

supplement #: S179
Guidant Corp. Feb 22, 2019 change design/components/specifications/material  
valitude crt-p, visionist crt-p, valitude x4 crt-p, visionist x4 crt-p

supplement #: S180
Guidant Corp. May 23, 2019 change design/components/specifications/material  
accolade cardiac resynchronization therapy pacemakers

supplement #: S181
Guidant Corp. Feb 19, 2019 process change - manufacturer/sterilizer/packager/supplier  
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