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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.
 
DevicePRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS
Generic Namestent, carotid
Applicant
Cordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP030047
Supplement NumberS019
Date Received02/16/2010
Decision Date02/14/2011
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN COLORANT USED IN THE CATHETERS OF THE PRECISE AND SMART NITINOL STENT SYSTEMS.
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