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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.
 
DeviceHEART WARE VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP100047
Supplement NumberS033
Date Received11/18/2013
Decision Date02/13/2014
Product Code DSQ 
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
Approval Order Statement  
APPROVAL FOR USE OF A NEW FORMULATION OF THE THERMOPLASTICVULCANIZATE (TPZ) MATERIAL USED IN THE MANUFACTURE OF THE MONITOR DATA CABLE, BATTERY PACK CABLE, DC ADAPTOR INPUT CABLE, AND ALARM SILENCE ADAPTOR COMPONENTS OF THE DEVICE.
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