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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.
 
DeviceFORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantCook Medical Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP100028
Supplement NumberS002
Date Received02/13/2012
Decision Date04/30/2012
Product Code NIN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE 4 MM VERSION OF THE STENT TO BE USED WITH THE FORMULA 414 RX DELIVERY SYSTEM.
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