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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINVIVE, INLIVEN, INTUA, VALITUDE, VALITUDE X4 (CRT-P RESYNCHRONIZATION DEVICES
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS115
Date Received11/20/2014
Decision Date01/06/2015
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
  We welcome your comments and feedback about Devices@FDA.
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