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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MVS83
MOUNDS VIEW, MN 55112
PMA NumberP140017
Date Received08/21/2014
Decision Date01/27/2015
Product Code NPV 
Docket Number 15M-0266
Notice Date 01/27/2015
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL THE MELODY TRANSCATHETER PULMONARY VALVE (TPV) AND THE ENSEMBLE TRANSCATHETER VALVE DELIVERYSYSTEM. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO SURGERY IN THE MANAGEMENT OF PEDIATRIC AND ADULT PATIENTS WITH THE FOLLOWING CLINICAL CONDITIONS:1) EXISTENCE OF A FULL (CIRCUMFERENTIAL) RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT THAT WAS EQUAL TO OR GREATER THAN 16 MM IN DIAMETER WHEN ORIGINALLY IMPLANTED, AND 2) DYSFUNCTIONAL RVOT CONDUIT WITH A CLINICAL INDICATION FOR INTERVENTION, AND: A) REGURGITATION >= MODERATE REGURGITATION, AND/OR B) STENOSIS: MEAN RVOT GRADIENT >= MMHG.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 
S027 S028 S029 
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