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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 NameCONTEGRA PULMONARY VALVED CONDUIT
Classification Namepulmonic valved conduit
Generic Namepulmonic valved conduit
Applicant
Medtronic, Inc.
1851 e. deere ave.
santa ana, CA 92705
HDE NumberH020003
Supplement NumberS016
Date Received03/13/2013
Decision Date04/14/2013
Product Code
MWH[ Registered Establishments with MWH ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
In accordance with 613(b) of the food and drug administration safety and innovation act (fdasia), a determination that your humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that the device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). Approval order for the contegra® pulmonary valved conduit. The device is indicated for use in patients under 18 years of age for the correction or reconstruction of the right ventricular outflow tract (rvot) in the following congenital heart malformations: pulmonary stenosis, tetralogy of fallot, truncus arteriosus, transposition with ventricular septal defect (vsd), pulmonary atresia; in addition, your device is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits. You may continue selling your device for profit as long as the number of devices distributed in any calendar year does not exceed the annual distribution number (adn). The adn for this device has been determined to be 4,000.
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