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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.
 
DeviceLatitude™ NXT Patient Management System (INVIVE, INTUA, VISIONIST, VALITUDE)
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS238
Date Received04/19/2024
Decision Date07/18/2024
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  
server and communicator software updates for the LATITUDE NXT System including both LATITUDE Wave Communicator model 6290 and LATITUDE NXT Server Software model 6460.
  We welcome your comments and feedback about Devices@FDA.
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