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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.
 
DeviceSTARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
Generic NameHEART-VALVE, MECHANICAL
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP870038
Date Received06/29/1987
Decision Date09/27/1991
Withdrawal Date 01/28/2022
Product Code LWQ 
Docket Number 91M-0420
Notice Date 11/14/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S004 S005 S007 S008 S009 S010 S011 
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