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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.
 
DeviceZILVER VASCULAR STENT AND SILVER VASCULAR STENT
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
Cook Incorporated
p.o.box 489
bloomington, IN 47402
PMA NumberP050017
Supplement NumberS005
Date Received02/19/2010
Decision Date04/12/2010
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised product labeling.
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