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 | PRECISE, PRECISE RX, AND PRECISE PRO RXNITINOL STENT SYSTEMS |
Generic Name | stent, carotid |
Applicant | Cordis US Corporation 14201 n.w. 60th avenue miami lakes, FL 33014 |
PMA Number | P030047 |
Supplement Number | S024 |
Date Received | 02/23/2012 |
Decision Date | 03/22/2012 |
Product Code |
NIM |
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 PACKAGE HANDLING CHANGE TO THE HEAT SEALING PROCESS. |
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