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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.
 
Trade NameSTARR EDWARDS SILASTIC BALL VALVE, MODELS 1260 AND 6120
Classification Nameheart-valve, mechanical
Generic Nameprosthetic heart valve model 1260 and 6120
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870038
Supplement NumberS007
Date Received08/17/2005
Decision Date09/13/2005
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in supplier of the ptfe monofilament sewing thread from w. L. Gore to lenzing ag.
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