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 | 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 | S002 |
Date Received | 11/24/2003 |
Decision Date | 03/19/2004 |
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 THE FOLLOWING CHANGE TO THE DELIVER SYSTEM OF THE S.M.A.R.T. CONTROL NITINOL STENT SYSTEM: 1) THE WIRE LUMEN OF THE DELIVERY SYSTEM WILL BE FABRICATED FROM DIFFERENT MATERIALS. 2) THE NEW WIRE LUMEN INNER DIAMETER SPECIFICATION HAS BEEN INCREASED. 3) THE PROXIMAL LAND SECTION OF THE DISTAL TIP HAS BEEN INCREASED. 4) THE INNER DIAMETER SPECIFICATION OF THE DISTAL TIP HAS BEEN INCREASE. |
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