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. |
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Device | SAMERT NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P020036 |
Supplement Number | S016 |
Date Received | 03/30/2010 |
Decision Date | 02/14/2011 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-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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