|
Device | 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 | S010 |
Date Received | 07/18/2008 |
Decision Date | 08/07/2008 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO INCORPORATE A FUNCTIONAL TORQUE SPECIFICATION FOR THE SLIDER ASSEMBLY OF THE SMART CONTROL NITINOL STENT DELIVERY SYSTEM. |