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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceINTUA
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP030005
Supplement NumberS101
Date Received07/30/2013
Decision Date08/22/2013
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE ETHYLENE OXIDE REMOVAL PHASE.
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