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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Classification Namestent, renal
Generic Namestent, renal
Applicant
COOK MEDICAL INCORPORATED
750 daniels way
p.o. box 489
bloomington, IN 47402-0489
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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