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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.
 
DeviceMelody TPV System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMedtronic, Inc.
8200 Coral Sea St. NE Mvs83
Mounds View, MN 55112
PMA NumberP140017
Supplement NumberS011
Date Received09/26/2018
Decision Date10/30/2018
Product Code NPV 
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 a dimensional change to the Platinum-Iridium marker bands on the Ensemble II Transcatheter Valve Delivery System.
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