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 NITINOL STENT SYSTEM AND 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 | S024 |
Date Received | 04/23/2012 |
Decision Date | 05/22/2012 |
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 CHANGES TO THE SEALING EQUIPMENT AND ADDITIONS TO IMPROVE THE VISUAL INSPECTION PROCESS. |
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