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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.
 
DeviceHEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral SeaSt. N.E.
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS032
Date Received12/06/2013
Decision Date03/26/2014
Product Code DSQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00751972
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE OF THE THREAD LOCKING ADHESIVE USED ON THERETENTION NUT WHICH SECURES THE CONNECTOR TO THE CONTROLLER HOUSING.
Post-Approval StudyShow Report Schedule and Study Progress
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