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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 #: S161
Guidant Corp. Dec 13, 2017 change design/components/specifications/material  
valitude / valitude x4 / visionist / visionist x4 / accolade cardiac resynchronization therapy pacemaker (crt-p) devices

supplement #: S162
Guidant Corp. Oct 18, 2017 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4, visionist, visionist x4 - accolade cardiac resynchronization therapy

supplement #: S163
Guidant Corp. Oct 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
accolade cardiac resynchronization therapy-pacemaker (crt-p): valitude, valitude x4, visionist, visionist x4

supplement #: S164
Guidant Corp. Oct 20, 2017 process change - manufacturer/sterilizer/packager/supplier  
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S165
Guidant Corp. Jan 07, 2018 change design/components/specifications/material  
valitude, valitude x4, visionist, visionist x4 (accolade (crt-ps), intua, invive (ingenio crt-ps)

supplement #: S166
Guidant Corp. Dec 01, 2017 process change - manufacturer/sterilizer/packager/supplier  
accolade cardiac resynchronization therapy-pacemaker (crt-p) devices: valitude, valitude, and visionist

supplement #: S167
Guidant Corp. Dec 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4, visionist, visionist x4, invive, intua cardiac resynchronization therapy-pacemaler (crt-p)

supplement #: S168
Guidant Corp. Dec 06, 2017 process change - manufacturer/sterilizer/packager/supplier  
valitude / valitude x4 / visionist / visionist x4 / accolade c ardiac resynchronization therapy-pacemaker (crt-p) device

supplement #: S169
Guidant Corp. Dec 06, 2017 process change - manufacturer/sterilizer/packager/supplier  
intua, invive, valitude, visionist, crt-ps

supplement #: S170
Guidant Corp. Dec 19, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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