|
Device | SMART CONTROL VASCULAR STENT SYSTEMS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P120002 |
Supplement Number | S004 |
Date Received | 05/12/2014 |
Decision Date | 06/13/2014 |
Product Code |
NIP |
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 IMPLEMENTATION OF A NEW ULTRASONIC WELDER TO BE USED BY THE SUPPLIER OF THE HEMOSTASIS VALVE OF THE SLIDER ASSEMBLY. |