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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNIRXCELL COCR CORONARY STENT ON RX SYSTEM
Classification Namestent, coronary
ApplicantMEDINOL LTD.
PMA NumberP110004
Supplement NumberS001
Date Received02/26/2013
Decision Date12/19/2013
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the stent delivery system. The device, as modified, will be marketed under the trade name nirxcell cocr coronary stent on rx system and 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 ¿30mm) with a reference vessel diameter of 2. 50mm to 4. 00mm.
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