|
Device | SUTURE MEDIATED CLOSURE SYSTEMS & ASSOCIATED ACCESSORIES |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S065 |
Date Received | 05/28/2009 |
Decision Date | 07/09/2009 |
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 A MANUFACTURING SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO FOR ETHYLENE OXIDE STERILIZATION. |