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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.
 
DeviceCordis PRECISE Nitinol Stent System
Generic Namestent, carotid
Applicant
Cordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP030047
Supplement NumberS040
Date Received05/01/2020
Decision Date05/29/2020
Product Code NIM 
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 
Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.
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