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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
Classification Nameventricular (assist) bypass
Generic Nameventricular (assist) bypass
Applicant
Medtronic
8200 coral seast. n.e.
mounds view, MN 55112
PMA NumberP100047
Supplement NumberS033
Date Received11/18/2013
Decision Date02/13/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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