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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 TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MVS83
MOUNDS VIEW, MN 55112
PMA NumberP140017
Supplement NumberS005
Date Received09/01/2016
Decision Date02/24/2017
Product Code NPV 
Docket Number 17M-1227
Notice Date 03/10/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT00688571
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
Approval for the Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System, and Ensemble II Transcatheter Valve Delivery System for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has >= moderate regurgitation and/or a mean RVOT gradient >= 35 mmHg.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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