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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 NameSUPERA PERIPHERAL STENT SYSTEM
Classification Namestent, superficial femoral artery
ApplicantABBOTT VASCULAR (IDEF TECHNOLOGIES INC)
PMA NumberP120020
Date Received11/16/2012
Decision Date03/28/2014
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 14M-0434
Notice Date 04/21/2014
Advisory Committee Cardiovascular
Clinical Trials NCT00933270
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the supera® peripheral stent system. This device is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery, with reference vessel diameters of 4. 0 to 6. 5 mm, and lesion lengths up to 140 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S004 S005 
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