|
Device | VASCULAR SOLUTIONS DUETT SEALING DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S007 |
Date Received | 11/28/2001 |
Decision Date | 12/31/2001 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT STRATIFIES ADVERSE EVENTS INTO DIAGNOSTIC AND INTERVENTIONAL PATIENT POPULATIONS. |