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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 NameFORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
Classification Namestent, renal
ApplicantCOOK MEDICAL INCORPORATED
PMA NumberP100028
Supplement NumberS002
Date Received03/08/2012
Decision Date04/30/2012
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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