|
Device | ANGIOLINK VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P040022 |
Date Received | 04/26/2004 |
Decision Date | 11/03/2004 |
Withdrawal Date
|
10/12/2010 |
Product Code |
MGB |
Docket Number | 04M-0496 |
Notice Date | 11/12/2004 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EVS VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR PERCUTANEOUS FEMORAL ARTERY APPROXIMATION. THE EVS VASCULAR CLOSURE SYSTEM IS ALSO INDICATED TO REDUCE TIME TO HEMOSTASIS AT FEMORAL PUNCTURE SITES AND TO REDUCE TIME TO AMBULATION FOR PATIENTS UNDERGOING DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 6-8 FRENCH PROCEDURAL SHEATHS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 |