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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIRXCELL COCR CORNARY STENT ON RX
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDINOL LTD.
kiryat atidim, bldg. 7
entrance a, p.o.b. 58165
tel-aviv 61581
PMA NumberP110004
Supplement NumberS006
Date Received05/05/2014
Decision Date06/04/2014
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ELIMINATING A REDUNDANT INSPECTION STEP AND REMOVING AN UNNECESSARY LABELING STEP.
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