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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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240 supplements returned for P030005

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Device Name Company Date Approved Supplement Reason Other Information
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173

supplement #: S088
Guidant Corp. Mar 12, 2013 change design/components/specifications/material Approval Order
contak renewal tr crt-ps, contak renewal tr 2 crt-ps, invive crt-ps

supplement #: S089
Guidant Corp. Nov 07, 2012 process change - manufacturer/sterilizer/packager/supplier  
contak & renewal tr family, crt-p

supplement #: S090
Guidant Corp. Nov 09, 2012 process change - manufacturer/sterilizer/packager/supplier  
intua cardiac resynchronization therapy-pacemaker (crt-p)

supplement #: S092
Guidant Corp. May 23, 2013 change design/components/specifications/material Approval Order
contak renewal tr cardiac resynchronization therapy pacemaker (crt-p) family

supplement #: S093
Guidant Corp. Dec 05, 2012 process change - manufacturer/sterilizer/packager/supplier  
invive crt-p

supplement #: S094
Guidant Corp. Jan 10, 2013 process change - manufacturer/sterilizer/packager/supplier  
invive cardiac resynchronization therapy - pacemaker (crt-p)

supplement #: S096
Guidant Corp. Jan 15, 2013 process change - manufacturer/sterilizer/packager/supplier  
invive cardiac resynchronization therapy -pacemaker (crt-p)

supplement #: S097
Guidant Corp. Apr 25, 2013 process change - manufacturer/sterilizer/packager/supplier  
contak renewwal tr invive families

supplement #: S098
Guidant Corp. Jun 06, 2013 process change - manufacturer/sterilizer/packager/supplier  
invive,intua cardiac resynchronization therapy-pacemakers (crt-p)

supplement #: S099
Guidant Corp. Jul 25, 2013 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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