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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Classification Namestent, renal
ApplicantCOOK MEDICAL INCORPORATED
PMA NumberP100028
Date Received07/19/2010
Decision Date01/14/2011
Product Code
NIN[ Registered Establishments with NIN ]
Docket Number 11M-0056
Notice Date 01/26/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00631540
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the formula balloon- expandable renal stent system. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic lesion (<= 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4. 0 - 7. 0 mm. Supoptimal ptra is defined as >= 50% residual stenosis, >= 20 mmhg systolic or >= 10 mmhg mean translesional pressure gradient, or flow-limiting dissection.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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