|
Device | StarClose SE Vascular Surgical System |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S037 |
Date Received | 11/13/2018 |
Decision Date | 02/21/2019 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization site located at Sterigenics UK Limited Cotes Park Lane Somercotes, Alfreton DE55 4NJ United Kingdom. |