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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.
 
DeviceNIRFLEX PREMOUNTED CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 8, P.O.B. 58165
Tel Aviv 6158101
PMA NumberP020040
Supplement NumberS006
Date Received02/28/2007
Decision Date03/29/2007
Withdrawal Date05/30/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF A NEW STENT CLEANING RACK DURING THE FINAL CLEANING PROCESS IN THE MANUFACTURE OF THE DEVICE.
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