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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
invive, intua

supplement #: S100
Guidant Corp. Jul 03, 2013 process change - manufacturer/sterilizer/packager/supplier  
intua

supplement #: S101
Guidant Corp. Aug 22, 2013 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr and invive crt-p systems

supplement #: S102
Guidant Corp. Sep 25, 2013 process change - manufacturer/sterilizer/packager/supplier  
intua

supplement #: S103
Guidant Corp. Oct 10, 2013 process change - manufacturer/sterilizer/packager/supplier  
invive,intua crt-ps

supplement #: S104
Guidant Corp. Nov 26, 2013    
cardiac resynchronization therapy-pacemaker (crt-p) invive and intua models

supplement #: S105
Guidant Corp. Feb 27, 2014 process change - manufacturer/sterilizer/packager/supplier  
contak renewal tr, invive, intua families of crt-ps

supplement #: S106
Guidant Corp. May 02, 2014 labeling change - indications/instructions/shelf life/tradename  
invive crt-p family

supplement #: S107
Guidant Corp. May 15, 2014 change design/components/specifications/material  
invive and intua crt ps

supplement #: S108
Guidant Corp. Apr 29, 2014 process change - manufacturer/sterilizer/packager/supplier  
invive crt ps, intua crt ps

supplement #: S109
Guidant Corp. May 28, 2014 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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