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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 Coronary Stent on RX System
Generic NameSTENT, CORONARY
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, P.O.B. 58165
Tel-Aviv 61581
PMA NumberP110004
Supplement NumberS028
Date Received02/21/2018
Decision Date04/17/2018
Withdrawal Date11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of two new balloon manufacturing machines.
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