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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
17590 gillette ave.
irvine,, CA 92614
PMA NumberP970002
Date Received01/24/1997
Decision Date09/30/1997
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 98M-0200
Notice Date 04/07/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Monostrut(TM) Cardiac Valve Prosthesis. This device is indicated for the replacement of malfunctioning native or prosthetic mitral (sizes 27, 29, 31, and 33 mm) or aortic (sizes 21, 23, 25, 27, 29, 31, and 33 mm) heart valves.
Supplements: S001