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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.
 
DeviceINGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGuidant Corp.
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP030005
Supplement NumberS113
Date Received07/25/2014
Decision Date10/21/2014
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
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 INGENIO CRT-P DEVICES (INVIVE CRT-P MODELS V172, V173; INTUA CRT-P MODELS V272, V273); INGENIO 2 CRT-P DEVICES (VALITUDE MODEL U125; VALITUDE X4 MODEL U128).
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