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. |
|
Device | DUETT PRO SEALING DEVICE, MODEL 1010 |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S028 |
Date Received | 10/21/2008 |
Decision Date | 12/17/2008 |
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 TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS. |
|
|