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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.
 
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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