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 | Cordis 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 | S042 |
Date Received | 05/01/2020 |
Decision Date | 05/29/2020 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility. |
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