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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150)
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 E. Deere Ave.
Santa Ana, CA 92705
PMA NumberP870078
Supplement NumberS031
Date Received01/29/2016
Decision Date04/28/2016
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).
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