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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.
Classification Namestent, coronary
Generic Namestent, coronary
kiryat atidim, bldg. 7
entrance a, p.o.b. 58165
tel-aviv 61581
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S010 S011 S012 
S013 S014 S017 S019 S020