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Device | CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. 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 | S008 |
Date Received | 08/24/2007 |
Decision Date | 09/20/2007 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ESTABLISHMENT OF AN ADDITIONAL SPECIFICATION FOR A BISMUTH SUBCARBONATE BLEND RAW MATERIAL. |