|
Device | STARCLOSE SE VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S031 |
Date Received | 07/18/2013 |
Decision Date | 01/16/2014 |
Product Code |
MGB |
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 THE USE OF AN INTERNAL FACILITY AS AN ADDITIONAL SUPPLIER OF THREE EXTRUDED COMPONENTS. |