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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 NumberS011
Date Received05/07/2002
Decision Date10/29/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the omnicarbon cardiac valve prosthesis in the additional size of 21 mm of the model 3313 (aortic) and size 25 mm of the model 3523 (mitral). The supplement requested approval of these sizes as an addition to the existing, approved (july 26, 2001; p830039/s007) product line of aortic sizes 23, 25, 27 and 29 mm, and mitral sizes 27, 29, 31, and 33 mm. The device is indicated for the replacement of malfunctioning native or prosthetic aortic and mitral valves.