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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/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.
 
DevicePRESILLION PLUS COCR CORONARY STENT RX SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDINOL LTD.
KIRYAT ATIDIM, BLDG. 7
ENTRANCE A, P.O.B. 58165
TEL-AVIV 61581
PMA NumberP110004
Date Received02/09/2011
Decision Date04/12/2012
Withdrawal Date 11/02/2020
Product Code MAF 
Docket Number 12M-0407
Notice Date 05/01/2012
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 
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