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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namepulmonary valve prosthesis percutaneously delivered
Generic Namepulmonary valve prosthesis percutaneously delivered
Medtronic, Inc
8200 coral sea street ne mvs83
mounds view, MN 55112
HDE NumberH080002
Date Received08/29/2008
Decision Date01/25/2010
Product Code
NPV[ Registered Establishments with NPV ]
Docket Number 10M0063
Advisory Committee Cardiovascular
Clinical Trials NCT00740870
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the medtronic melody® transcatheter pulmonary valve (model pb 10) and medtronic ensemble® transcatheter valve delivery system (nu1 0). This device is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: a existence of a full (circumferential) rvot conduit that was equal to or greater than 16 num in diameter when originally implanted and dysfunctional right ventricular outflow tract (rvot) conduits with a clinical indication for intervention, and either: 1) regurgitation: > moderate regurgitation, or 2) stenosis: mean rvot gradient > 35 mmhg.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S011 
S013 S014 S015 S016 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030