Premarket Approval (PMA)

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.

• Device: S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
• Generic Name: STENT, ILIAC
• Applicant: Cordis US Corporation; 14201 N.W. 60th Avenue; Miami Lakes, FL 33014
• PMA Number: P020036
• Date Received: 09/05/2002
• Decision Date: 08/12/2003
• Product Code: NIO
• Docket Number: 03M-0381
• Notice Date: 08/26/2003
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM. THE DEVICES ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4 TO 9 MM, AND ANGIOGRAPHIC EVIDENCE OF A PATIENT PROFUNDA OR SUPERFICIAL FEMORAL ARTERY.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 ; S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 ; S025 S026 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 ; S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 ; S050 S052 S053 S054