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 | PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS |
Generic Name | stent, carotid |
Applicant | Cordis US Corporation 14201 n.w. 60th avenue miami lakes, FL 33014 |
PMA Number | P030047 |
Supplement Number | S020 |
Date Received | 02/16/2010 |
Decision Date | 03/17/2010 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN PACKAGING CONFIGURATION. |
|
|