|
Device | SMART & SMART CONTROL NITINOL STENT SYSTEMS |
Generic Name | STENT, ILIAC |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P020036 |
Supplement Number | S020 |
Date Received | 08/09/2010 |
Decision Date | 01/31/2011 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE TO THE TEMPERATURE SET POINT IN YOUR SUB- ASSEMBLY PROCESS. |