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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 NameSMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
ApplicantCORDIS CORP.
PMA NumberP120002
Date Received02/03/2012
Decision Date11/07/2012
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 12M-1183
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00739102
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the s. M. A. R. T. Control and s. M. A. R. T. Vascular stent systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 
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