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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameMELODY TRANSCATHETER PULMONARY VALVE
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
HDE NumberH080002
Supplement NumberS007
Date Received03/01/2012
Decision Date01/10/2013
Product Code
NPV[ Registered Establishments with NPV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the glutaraldehyde stock solution that is obtained from dow chemical for the fixative, storage, and sterilization solutions to be changed from a 25%stock solution to a 50% stock solution and is indicated for the following uses: for the contegra pulmonary valved conduit: correction or reconstruction of the right ventricular outflow tract (rvot) in patients aged less than 18 years with any of the following congenital heart malformations:1) pulmonary stenosis2)tetralogy of fallot" truncus arteriosus3) transposition with ventricular septal defect (vsd)" pulmonary atresia. In addition, the conduit is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits. For the melody transcatheter pulmonary valve:as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: " -existence of a full (circumferential) rvot conduit that was equal to or greater than 16 mm in diameter when originally implanted and "dysfunctional right ventricular outflow tract (ryot) conduits with a clinicalindication for intervention, and either:a) regurgitation: ! moderate regurgitation, orb) stenosis: mean rvot gradient>: 35 mmhg.
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