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 | DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S019 |
Date Received | 05/16/2003 |
Decision Date | 06/13/2003 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SHELF-LIFE EXTENSION OF THE TRIS DILUENT COMPONENT, FOR THE DEVICES LISTED ABOVE, FROM THE APPROVED 24 MONTHS TO 36 MONTHS. |
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