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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.
 
DeviceHANCOCK APICAL LEFT VENTRICLE CONNECTOR
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 E. Deere Avenue
Santa Ana, CA 92705
PMA NumberP870078
Supplement NumberS008
Date Received03/31/2010
Decision Date09/20/2010
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HANCOCK APICAL LEFT VENTRICLE CONNECTOR, MODEL 174A. THE DEVICE IS INDICATED FOR PROVIDING AN ALTERNATIVE METHOD FOR RELIEF OF LEFT VENTRICULARHYPERTENSION IN PATIENTS WITH SEVERE LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION DUE TO HYPOPLASIA OFTHE AORTIC ROOT, HYPOPLASIA OF THE AORTIC ANNULUS, OR ACQUIRED PROBLEMS SECONDARY TO AORTIC VALVE REPLACEMENT WHICH CANNOT BE RELIEVED THROUGH CONVENTIONAL TECHNIQUES.
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