Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VASCULAR SOLUTION DUETT SEALING DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S008 |
Date Received | 12/11/2001 |
Decision Date | 05/29/2002 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES. |
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