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. |
|
Device | S.M.A.R.T NITINOL STENT SYSTEM & 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 | S004 |
Date Received | 06/19/2006 |
Decision Date | 07/19/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE COINING AND RIVETING PROCESS OF THE TANTALUM MICROSMARKERS TO THE S.M.A.R.T. CONTROL STENT. |
|
|