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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 NumberS024
Date Received07/17/2017
Decision Date03/07/2018
Withdrawal Date11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Creganna Medical, 8 Admiralty Street, #07-10 Admirax Building, Singapore, for the manufacturing of D-Catheter delivery system.
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