|
Device | CORDIS PRECISE 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 | S012 |
Date Received | 02/06/2008 |
Decision Date | 09/10/2008 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE INCOMING INSPECTION SPECIFICATIONS FOR THE RAW MATERIAL USED FOR THE HYPOTUBE COMPONENT. |