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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)
Classification Namepulmonary valve prosthesis percutaneously delivered
Generic Namepulmonary valve prosthesis percutaneously delivered
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
mvs83
mounds view, MN 55112
PMA NumberP140017
Date Received08/21/2014
Decision Date01/27/2015
Product Code
NPV[ Registered Establishments with NPV ]
Docket Number 15M-0266
Notice Date 01/27/2015
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 
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