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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 PROSTHESIS,MODELS 1260 & 6120
Classification Nameheart-valve, mechanical
Generic Nameprosthetic heart valve model 1260 and 6120
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP870038
Supplement NumberS005
Date Received04/08/2005
Decision Date07/20/2005
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate supplier of polyethylene tetrafluoroethylene (ptfe) thread, namely w. L. Gore, and for a change from multifilament ptfe thread to monofilament ptfe thread used in the final sewing of the cloth to complete the sewing ring of the starr-edwards silastic ball prosthesis, models 1260 & 6120.
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