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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 crt-p

supplement #: S120
Guidant Corp. May 19, 2015 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p

supplement #: S121
Guidant Corp. May 19, 2015    
invive,intua,visionist,valitude crt-ps

supplement #: S122
Guidant Corp. Jul 21, 2015 change design/components/specifications/material  
cardiac resynchronization therapy -pacemaker (crt p) valitude: u125 and u128

supplement #: S123
Guidant Corp. May 31, 2015 process change - manufacturer/sterilizer/packager/supplier  
valitude, valitude x4 crt-ps

supplement #: S124
Guidant Corp. Jul 16, 2015 process change - manufacturer/sterilizer/packager/supplier  
valitude and valitude x4 crt-p

supplement #: S125
Guidant Corp. Jul 20, 2015 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-ps

supplement #: S126
Guidant Corp. Jul 20, 2015 process change - manufacturer/sterilizer/packager/supplier  
valitude crt-p

supplement #: S128
Guidant Corp. Aug 08, 2015    
valitude (model u125), valitude x4 (model u128) crt-ps

supplement #: S129
Guidant Corp. Nov 03, 2015 change design/components/specifications/material  
ingenio 2 crt-p, valitude & valtitude x4 crt-ps

supplement #: S130
Guidant Corp. Nov 19, 2015 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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