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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP040021
Supplement NumberS004
Date Received09/29/2006
Decision Date11/15/2007
Product Code
DYE[ Registered Establishments with DYE ]
Docket Number 08M-0084
Notice Date 02/05/2008
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the epic valve in aortic sizes 21, 23, 25, 27 and 29 mm, and in mitral sizes 27, 29, 31 and 33 mm, and the sjm epic supra valve in aortic valve sizes 19, 21, 23, 25 and 27 mm. The device is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling