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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 crt-p resynchronization devices

supplement #: S131
Guidant Corp. Feb 05, 2016 change design/components/specifications/material  
valitude , valitude x4 crt-ps

supplement #: S132
Guidant Corp. Feb 03, 2016 process change - manufacturer/sterilizer/packager/supplier  
contak renewal models h125 and h120 with the model 2865 version 1.8 application software

supplement #: S133
Guidant Corp. May 03, 2016 change design/components/specifications/material  
crt-p resynchronization devices: invive, intua, visionist, valitude

supplement #: S134
Guidant Corp. Jul 08, 2016 change design/components/specifications/material  
valitude, valitude x4, invive, intua

supplement #: S135
Guidant Corp. May 25, 2016 process change - manufacturer/sterilizer/packager/supplier  
cardiac resynchronization therapy- pacemaker (crt-p); invive and intua models. ingenio 2. valitude model u125 ; valitud

supplement #: S136
Guidant Corp. May 25, 2016 process change - manufacturer/sterilizer/packager/supplier  
ingenio™ 2 crt-p devices; valitude™ model: u125; valitude™ x4 model: u128

supplement #: S137
Guidant Corp. Jun 20, 2016 process change - manufacturer/sterilizer/packager/supplier  
visionist, visionist x4, valitude, valitude x4, invive, intua

supplement #: S138
Guidant Corp. Dec 16, 2016 change design/components/specifications/material  
valitude crt-p

supplement #: S139
Guidant Corp. Aug 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p, accolade crt-p

supplement #: S140
Guidant Corp. Aug 10, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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