|
Device | PRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P030047 |
Supplement Number | S016 |
Date Received | 12/03/2008 |
Decision Date | 12/24/2008 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS PRECISE STENT SYSTEMS. |