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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 Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
9725 south robert trail
inver grove heights, MN 55077
PMA NumberP830039
Supplement NumberS007
Date Received10/24/1996
Decision Date07/26/2001
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 01M-0380
Notice Date 09/05/2001
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 omnicarbon(tm) cardiac valve prosthesis, aortic model 3313 in sizes 23, 25, 27, and 29 mm, and mitral supra-annular model 3523 in sies 27, 29, 31, and 33 mm. The device is indicated for the replacement of dysfunctioning native or prosthetic aortic or mitral heart valves.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling