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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NamePRESILLION PLUS COCR CORONARY STENT RX SYSTEM
Classification Namestent, coronary
ApplicantMEDINOL LTD.
PMA NumberP110004
Date Received02/09/2011
Decision Date04/12/2012
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 12M-0407
Notice Date 05/01/2012
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the presillion plus cocr coronary stent on rx system. This device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length <= 30 mm) with a reference vessel diameter of 2. 50 mm to 4. 00mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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