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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSTARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
Classification Nameheart-valve, mechanical
Generic Nameprosthetic heart valve model 1260 and 6120
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP870038
Date Received06/29/1987
Decision Date09/27/1991
Product Code
LWQ[ Registered Establishments with LWQ ]
Docket Number 91M-0420
Notice Date 11/14/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S004 S005 S007 S008 S009 S010 
S011 
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