|
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 | S023 |
Date Received | 11/02/2009 |
Decision Date | 01/27/2010 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO INCREASE THE CLEARANCE OF THE CLIP DELIVERY TUBE AND MINOR MODIFICATIONS TO THE EXCHANGE SYSTEM AND SHEATH SPLITTER FOR THE DEVICE. |