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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP870038
Supplement NumberS011
Date Received10/06/2006
Decision Date01/19/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MINOR DESIGN CHANGE AND CHANGE IN MATERIAL SUPPLIER.
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