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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 BALLOON-EXPANDABLE RENAL STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantCook Medical Incorporated
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP100028
Supplement NumberS003
Date Received01/28/2013
Decision Date03/28/2014
Product Code NIN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.
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